A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)
Phase: PHASE3
Conditions: Emergency Contraception
Sponsor: HRA Pharma

 
HRA Pharma 
 
 
ELLA® ACTUAL USE TRIAL PROTOCOL 
 
 
Title: 
A Multi-Center, Open-Label Trial Investigating 
Behavior Related to ella® Use in a Simulated OTC 
Environment (LIBRella) 
Compound: 
ulipristal acetate 30 mg 
Phase: 
Phase IV 
Protocol Number: 
151032-001 
Protocol Version / Date: 
Final v3.1 / 5 May 2017 
Sponsor’s Name and 
Address:  
Laboratoire HRA Pharma 
15 rue Beranger 
75003 PARIS  
France 
 
Pharmacovigilance Contact 
Information 
HRA Pharma Pharmacovigilance  
15 rue Béranger 75003 PARIS,  
fax: + 33 1.42.77.03.52  
e-mail : pharmacovigilance@hra-pharma.com 
 
24-Hour Adverse Event 
Reporting Number 
1-800-530-3680 
 
 
The information contained in this document is proprietary and confidential and is intended for the 
exclusive use of the designated addressee. Any disclosure, reproduction, distribution, or other 
dissemination of this information outside of HRA Pharma or its Affiliates, Licensees, or their 
Regulatory Agencies is strictly prohibited. If you have received this document in error, please 
contact HRA Pharma. 

Sarah Farnsworth
Digitally signed by Sarah Farnsworth 
DN: cn=Sarah Farnsworth, o=PEGUS Research, Inc., ou=VP, 
Scientific Affairs, email=FarnsworthS@pegus.com, c=US 
Reason: I am approving this document 
Date: 2017.05.16 08:54:37 -06'00'
Russell D. Bradford
Digitally signed by Russell D. Bradford 
DN: cn=Russell D. Bradford, o=PEGUS Research, 
Inc., ou, email=bradfordr@pegus.com, c=US 
Date: 2017.05.16 08:55:34 -06'00'

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Actual Use Trial Protocol 151032-001 
 
 
Final v3.1  5May2017 
 
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Document History 
 
Document 
Version / Date 
Summary of Changes 
Final protocol 
Final v1.0_22Dec2016 
n/a 
Amended protocol 
Final v1.1_26Jan2017 
In response to IRB review: 
Schedule of Activities updated to 
include specification on timing and 
method of subject study drug 
payment reimbursement. 
Section 3.3.1 Inclusion Criteria 
was updated to add “Seeking the 
use of emergency contraception”. 
Section 5.2.2 and Section 12.3 
clarification added that assent of 
adolescent subjects will be 
gathered where state or local laws 
do not allow for waiver of parental 
consent. 
Section 5.5 Flow chart of activities 
revised to include explicit consent 
to gather sensitive data. 
Section 12.3 Subject Information 
and Consent updated to specify 
retention of anonymous study data 
from screen fail, disqualified to 
participate and non-consented 
subjects. 
Sections 12.2 and 12.3 removed 
references to waiver of parental 
consent.  Removed reference to 
birth date as an example of PII 
collected and clarified that PII 
collected will be for compensation 
and follow-up purposed only. 
Sponsor decision throughout, 
revised number of health clinics 
from approximately 20 to 
approximately 25 thereby 
increasing total investigative sites 
to approximately 35. 

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Amended Protocol 
Final v2.0_06Mar2017 
The following changes were made 
in response to feedback received 
from FDA in a teleconference on 
24Feb2017:  
Added breastfeeding as an 
exclusion criterion to participate in 
Use Phase 
Added premenarchal status as an 
exclusion criterion to participate in 
Use Phase 
Urine-based pregnancy testing at 
enrollment was added as a study 
procedure to confirm pregnancy 
status prior to allowing subjects to 
purchase (as pregnancy is an 
exclusion criterion to participate in 
Use Phase).  
Section 5.5 Flow chart of activities 
revised to include new exclusion 
from Use Phase following positive 
pregnancy test at enrollment. 
Amended Protocol 
Final v3.0_27Apr2017 
The following changes were made 
in response to written comments 
received from FDA on 03-Apr-
2017, reference ID 4078573: 
Secondary Endpoint D reworded to 
reflect that breastfeeding was 
added as an exclusion criterion to 
the Use Phase in v2.0. 
Added Secondary Endpoint I 
Section 2.3: Additional relevant 
DFL messages added for 
Secondary Endpoint D. Secondary 
Endpoint I and rationale added 
Section 3.1 Added clarifying text 
that study staff will not answer 
subject questions about the IP, but 
will redirect them to the labeling.  
Section 3.3: Sample size 
increased to 175 for adolescents, 
with approximately 50 under the 

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age of 15 and 125 ages 15-17. 
Supplemental rationale for active 
recruitment of adolescents was 
added.  
Section 4.3.2: Rationale for 
maximum purchase of 9 packages 
of IP added.  
Section 5.5 Flow chart of activities 
revised to reflect revised approach 
to adolescent recruitment 
Section 6.3: Rationale for not 
imposing a low literacy quota in the 
study was added. 
Section 8.4.2: Complete definitions 
of Correct, Acceptable, and 
Incorrect Selectors added 
Section 8.4.3: Process for 
physician mitigation added.  
Section 9.3: Added a secondary 
analysis by subject rather than 
dosing instance for relevant 
endpoints. 
Section 9.3.3.1: Clarified analysis 
for Secondary Endpoint D 
Section 9.3.3.3: Clarified that other 
proportions will be presented with 
self-selection endpoints, such as 
[(cell A + cell D) / (cell A + cell B + 
cell C + cell D)] and [cell D/ (cell B 
+ cell D)]. 
Amended Protocol 
Final v3.0_27Apr2017 
In response to IRB review: 
References to adolescent 
recruitment changed from “targets” 
to “goals,” in the setting of capping 
enrollment for adults (to allow 
room for an adolescent subgroups 
of FDA-requested size). 
 
 

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Protocol Summary 
 
Study Title A Multi-Center, Open-Label Trial Investigating Behavior Related 
to ella® Use in a Simulated OTC Environment (LIBRella) 
Phase Phase IV 
Background and 
Rationale 
ella® (ulipristal acetate) is proposed for a prescription to over-the-
counter (Rx-to-OTC) switch. This actual use trial (AUT) will be 
conducted to demonstrate appropriate consumer behavior when 
using the product in the absence of a physician or other learned 
intermediary. This study will be conducted to obtain 
measurements of consumer behaviors related to the actual use of 
the product, in particular the compliance with key communication 
messages presented in the Drug Facts Label (DFL). 
Objective and 
Endpoints 
The objective of this study is to evaluate the adequacy of the 
proposed OTC labeling to guide appropriate consumer behavior 
by measuring pre-specified endpoints. The determination of the 
following primary endpoints and other measures is based on the 
potential clinical consequences of a consumer failing to heed 
each key label instruction and the concerns the United States 
Food and Drug Administration (US FDA) has raised with regard to 
the potential for misuse of the product in an OTC setting. 
Endpoints are designated either as Actual Use endpoints or Self-
Selection endpoints. 
Primary Endpoints 
A. Actual Use:  Proportion of dosing instances among user 
population taken within 120 hours (5 days) of most recent 
episode of unprotected sex. 
B. Actual Use:  Proportion of dosing instances among user 
population in which no more than one tablet was taken. 
C. Self-Selection:  Proportion of female selectors who are not 
pregnant at the time of selection decision. 
Secondary Endpoints 
D. Self-Selection:  Proportion of female selectors who are not 
breastfeeding at the time of selection decision. 
E. Self-Selection:  Proportion of self-selection population who 
make a correct selection decision. 
F. Actual Use:  Proportion of dosing instances among user 
population in which hormonal birth control (HBC) is not 
taken for 5 days after taking ella®. 
G. Actual Use:  Proportion of dosing instances among user 
population associated with use of hormonal contraceptives 
in the same cycle after taking ella® in which subject 
reports using a condom (or other barrier method) every 
time they have sex until their next menstrual period. 
H. Actual Use:  Proportion of user population who do not use 

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the study product more than once in the same menstrual 
cycle. 
I. Self-Selection/Actual Use:  Proportion of self-selection 
population taking one of the “ask a doctor or pharmacist 
before use” products who do not select, who select but do 
not use or who report contacting a healthcare provider or 
pharmacist.  
Other Measures 
J. Actual Use:  Proportion of user population who used a 
HBC method sometime during the previous two months. 
K. Actual Use:  Proportion of user population who use any 
EC on more than one occasion within the study period. 
L. Actual Use:  Proportion of user population who report 
becoming pregnant within the study period. 
Study Design  This is an observational open-label, multicenter, 6-week study 
designed to mimic an OTC-like environment in which subjects will 
use ella® after making a self-selection and purchase decision 
about the product based only on their reading of the DFL and 
other information on the package. The study will increase 
understanding regarding how subjects will use the medication in 
an OTC-like environment. 
Number of 
Subjects 
A total of approximately 950 subjects will be allowed to purchase 
the study medication. Assuming that about 80% of those who 
purchase will both use the study medication and participate in at 
least one follow up telephone call, that will yield an actual use 
population among which to evaluate the primary endpoints of 760 
subjects. In order to allow for a subgroup of adolescent users, 
adult purchasers will be constrained to no more than 775, 
allowing for an adolescent subgroup of approximately 175 (or 
more, should a higher proportion naturally occur). Among 
adolescents, enrollment will be further broken down to include 
approximately 50 purchasers under the age of 15 and 
approximately 125 purchasers ages 15-17. 
Methods The nature of the indication (emergency contraception, EC) 
makes recruitment for the trial challenging. By definition a woman 
does not know in advance that she will need EC, and when she 
does need it (i.e., after she has had unprotected sex), she needs 
to take it very quickly. Therefore, a typical passive advertising 
campaign aimed at consumers interested in the indication (the 
approach typically used in AUTs) is unlikely to be effective in this 
study.  
Subjects will be recruited at the point of OTC-like sale in women’s 
health clinics and in retail pharmacy study sites. Sites will be 
chosen which currently sell EC in an OTC or OTC-like setting and 
which have enough EC sales to meet recruitment goals. 
Approximately 35 sites will be used, composed of approximately 

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25 women’s health clinics and 10 retail pharmacy research sites. 
In order to be as representative as possible of the OTC EC-
seeking population, when potential subjects come to a site 
looking to purchase EC, they will be offered the opportunity to 
participate in the study. Potential subjects will be directed to study 
staff for a face-to-face interview and screened for initial study 
inclusion criteria. 
Subjects who meet the initial screening inclusion criteria for the 
study will be given an (empty) ella® package and will be allowed 
as much time as they need to review the information on the 
outside of the entire package. Subjects will be asked to make a 
selection decision regarding whether the product is appropriate 
for them to use or not.  Reasons for selection and deselection will 
be recorded.  Those that select the product will then be told the 
cost of the investigational product and will be asked if they would 
like to purchase it for their own use. Reasons for any non-
purchase and purchase decisions will be recorded.  
Following the purchase decision, subjects will provide 
demographic information and limited medical history. The Rapid 
Estimate of Adult Literacy in Medicine (REALM)1 or Rapid 
Estimate of Adolescent Literacy in Medicine (REALM-Teen)2 will 
then be administered. Subjects will be asked to sign the informed 
consent and then provide information about current medication 
use. Subjects who sign consent will provide a urine sample for 
pregnancy testing.  Subjects with a positive pregnancy test result 
will be informed that the test was positive, will be asked the 
selection and purchase question again to better assess their self-
selection decision, and then excluded from further study 
participation. Qualified subjects will be allowed to purchase the 
study product and told they may return to the site at any time to 
resupply. Subjects will not be allowed to purchase more than 3 
one-dose packages at a time or more than 9 one-dose packages 
during the study period (although this will not be communicated to 
the subjects unless they attempt to purchase more than that). 
While any request for more will be denied, the request will be 
recorded. 
Subsequent contact will be by up to two telephone interviews 
conducted by trained nurses (interviewers) at a central research 
site. Subjects will be contacted by phone at Week-2 (Day 14 with 
an allowable window of ±3 days) and at Week-6 (Day 42±4 days) 
to gather information on if, how and when the subject took the 
product, any adverse events (AEs), concomitant medications, and 
other actions the subject may have taken related to the use of the 
product. Results of the End-of-Study pregnancy test will be 
reported by subjects and recorded. 
Once all steps of the final telephone interview are completed, the 
subject will be instructed to return leftover study medication, if 
any, and empty packaging to PEGUS and will exit the study. 

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Statistical 
Analysis 
A summary of the disposition of subjects (including responders, 
self-selection population, purchasers and users) and reasons 
for exclusion from these populations will be provided. 
Demographic characteristics, medical history and other 
background information will be summarized for the responder, 
self-selection, purchaser, and user populations. 
Frequencies and percentages will be presented for categorical 
data, mean, standard deviation (SD); median, and range will be 
presented for numerical data. 
Frequencies, percentages and 2-sided 95% confidence 
intervals (CIs) will be calculated for the primary and secondary 
endpoints using the exact method. For the primary endpoints, it 
will be concluded that the established target threshold is 
reached if the lower limit of the CI of the point estimate is equal 
to or exceeds the value of the pre-determined threshold.  
Endpoints and demographics will be presented for subgroups of 
interest, with subjects dichotomized on the corresponding 
variables, which include (but are not necessarily limited to) 
literacy, gender, age (adolescent vs. adult women), and history of 
hormonal birth control use. 
Several of the endpoints are based on dosing instance, rather 
than by subject, as subjects have the potential to take more than 
one dose over the course of the study.  Correctness of selection 
or behavior can only be evaluated at the time of use, rather than 
at the time of purchase.  However, for each of those endpoints, a 
secondary analysis by subject will also be presented. 
A more detailed description of planned data analysis procedures 
will be found in the Statistical Analysis Plan (SAP) which will be 
approved and signed before the database is locked. 
Study Duration The duration of this study is expected to be around 6 months 
(from first subject enrolled in the study until last subject last visit), 
with subject recruitment proposed to start mid-Q2 2017 and end 
in Q4 2017. The actual overall study duration or subject 
recruitment period may vary. 
CRO PEGUS Research, Inc. 
331 South Rio Grande, Suite 100 
Salt Lake City, UT  84101 
Date 27 April 2017 
 

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Schedule of Activities 
 
The schedule of activities table provides an overview of the protocol visits and procedures. Refer to the STUDY PROCEDURES and  
ASSESSMENTS sections of the protocol for detailed information on each procedure and assessment required for compliance with 
the protocol. The investigator may schedule visits (unplanned visits) in addition to those listed on the schedule of activities, in order to 
conduct evaluations or assessments required to protect the well-being of the subject. 
Visit Procedure 
Intercept 
Recruitment  
Enrollment Visit / 
First Purchasea 
 
Week 2 
Week 6 
End of Study 
/ Early 
Terminatione 
  
 
Day 1 
14±3 Days 
42±4 Days 
 
Invitation to participate  
X 
 
 
 
 
Review screening / study inclusion criteria 
 
X 
 
 
 
Subject reviews outer packaging and makes 
selection and purchase decision 
 
X 
 
 
 
Collect demographics and relevant medical 
history 
 
X 
 
 
 
Administer REALM or REALM-Teen testc 
 
X 
 
 
 
Study exclusion/inclusion criteria assessed 
for eligibility to continue 
 
X 
 
 
 
Subject signs informed consent  
 
X 
 
 
 
Urine pregnancy test performedh 
 
X 
 
 
 
Collect current/regular relevant medications 
and associated conditionsb 
 
X 
 
 
 
Purchase transaction conductedd 
 
X 
 
 
 
Telephone interviews  
 
 
X 
X 
X 
End-of-study telephone interview 
 
 
 
 
X 
Record End-of-study pregnancy test resultsf 
 
 
 
 
X 
Concomitant medications 
 
X 
→ 
→ 
X 
Adverse Events 
 
X 
→ 
→ 
X 
Reimbursement for cost of study medication 
(After all subjects complete the study) g 
 
 
 
 
X 
Abbreviations: → = ongoing/continuous event; REALM = Rapid Estimate of Adult Literacy in Medicine; REALM-Teen = Rapid Estimate of 
Adolescent Literacy in Medicine 

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a. 
Day relative to first purchase of study medication (Day 1). 
b. 
Subjects will be asked to provide a list of any conditions they have and any medications they are taking. Females only. 
c. 
REALM or REALM-Teen will be conducted for all subjects who participate in the enrollment interview regardless of self-selection/purchase 
decision. 
d. 
Subjects will be allowed to purchase any amount of study medication up to 3 packages at the baseline visit, or return to the site at any time 
during their use phase and purchase the maximum amount (up to 9 packages) allowed during subsequent treatment weeks (6 weeks). 
e. 
Early termination interview will be conducted during the study if the subject is discontinued or withdraws consent prior to Week 6. 
f. 
Subjects are provided with a urine pregnancy test at enrollment and asked to keep it until directed to use it at the end of study. 
g. 
After study closeout, subjects are reimbursed the purchase price paid for any study drug.The subjects are not notified of this when enrolling in 
the study in order to maintain an OTC-like environment for selection/purchase of the study drug. Subjects will be notified of and provided with 
the reimbursement via mail following study closeout. 
h. 
Subjects with a positive pregnancy test will be asked to make a selection decision again to better assess self-selection and then will be 
excluded from the use phase. 
 
 

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Glossary and Abbreviations 
 
AE 
Adverse Event 
AUT 
Actual Use Trial 
CI 
Confidence Interval 
CIL 
Consumer Information Leaflet 
CRF 
Case Report Form 
CRO  
Contract Research Organization  
DCI 
Data Collection Instrument 
DFL 
Drug Facts Label 
DMP 
Data Management Plan 
EC 
Emergency Contraceptive 
EDC 
Electronic Data Capture 
EDP 
Exposure During Pregnancy 
EOS 
End-of-Study 
FDA 
Food and Drug Administration 
GCP  
Good Clinical Practice  
HBC 
Hormonal Birth Control 
HIV 
Human Immunodeficiency Virus 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IP 
Investigational Product 
IRB 
Institutional Review Board 
LCS 
Label Comprehension Study 
MedDRA 
Medical Dictionary for Regulatory Activities 
OTC 
Over-the-Counter 
PBOS 
Plan B One Step 
PHI 
Personal Health Information 
PII 
Personal Identifiable Information 
POP 
Progestin-Only Pill 
PT 
Preferred Term 
PV 
Pharmacovigilance 
REALM 
Rapid Estimate of Adult Literacy in Medicine 
REALM-Teen 
Rapid Estimate of Adolescent Literacy in Medicine 
Rx 
Prescription 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SOC 
System Organ Class 

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SOP 
Standard Operating Procedure 
SSS 
Self-Selection Study 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
UPA 
Ulipristal Acetate 
US 
United States 
USPS 
United States Postal Service 
 
 
 

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Table of Contents 
1 
INTRODUCTION ................................................................................................... 18 
1.1 
Indication ..................................................................................................... 18 
1.2 
Background and Rationale ........................................................................... 18 
2 
STUDY OBJECTIVE AND ENDPOINTS ................................................................ 18 
2.1 
Objective ...................................................................................................... 18 
2.2 
Endpoints ..................................................................................................... 18 
 
Primary Endpoints ............................................................................ 18 
 
Secondary Endpoints ....................................................................... 18 
 
Other Measures ................................................................................ 19 
2.3 
Rationale for Designation of Study Endpoints .............................................. 19 
3 
STUDY DESIGN .................................................................................................... 24 
3.1 
Naturalistic Design ....................................................................................... 24 
3.2 
Study Sites................................................................................................... 25 
 
Site Training and Procedural Integrity ............................................... 25 
3.3 
Subject Selection ......................................................................................... 25 
 
Inclusion Criteria: Self-Selection Phase ............................................ 26 
 
Exclusion Criteria: Use Phase .......................................................... 27 
 
Recruitment Methods ....................................................................... 27 
3.4 
Randomization ............................................................................................. 28 
3.5 
Data Collection ............................................................................................ 28 
3.6 
Test Materials .............................................................................................. 29 
3.7 
Study Administrative Structure ..................................................................... 29 
4 
STUDY TREATMENTS .......................................................................................... 29 
4.1 
Allocation to Treatment ................................................................................ 29 
4.2 
Breaking the Blind ........................................................................................ 29 
4.3 
Drug Supplies .............................................................................................. 29 
 
Formulation and Packaging .............................................................. 29 
 
Preparation and Dispensing ............................................................. 30 
 
Drug Storage and Accountability ...................................................... 30 
4.4 
Drug Administration ..................................................................................... 31 
 
Compliance ...................................................................................... 31 
4.5 
Concomitant Medication(s) .......................................................................... 31 
4.6 
Rescue/Escape/Salvage Therapy ................................................................ 31 
4.7 
Batch Recall ................................................................................................. 31 
5 
STUDY PROCEDURES ......................................................................................... 31 
5.1 
Pre-Interview Activities ................................................................................. 31 
5.2 
Study Period ................................................................................................ 32 

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Enrollment Visit, Self-Selection/Purchase Decision .......................... 32 
 
After Purchase Decision and Before Use Phase ............................... 32 
5.3 
Use Phase ................................................................................................... 33 
 
Unscheduled Study Site Visits .......................................................... 33 
 
Telephone Interviews ....................................................................... 33 
5.4 
Subject Withdrawal (Early Termination) ....................................................... 34 
5.5 
Study Flow ................................................................................................... 36 
6 
ASSESSMENTS .................................................................................................... 37 
6.1 
Screening Assessment ................................................................................ 37 
6.2 
Enrollment Interview .................................................................................... 37 
6.3 
Reading Level Assessment .......................................................................... 37 
6.4 
Interim Follow-Up Telephone Interviews ...................................................... 38 
6.5 
End-of-Study/Early Termination Telephone Interview .................................. 39 
6.6 
Pregnancy Testing ....................................................................................... 39 
7 
ADVERSE EVENT REPORTING ........................................................................... 40 
7.1 
Adverse Events ............................................................................................ 40 
7.2 
Reporting Period .......................................................................................... 40 
7.3 
Definition of an Adverse Event ..................................................................... 40 
7.4 
Abnormal Test Findings ............................................................................... 41 
7.5 
Serious Adverse Events ............................................................................... 41 
 
Protocol-Specified Serious Adverse Events ...................................... 42 
7.6 
Hospitalization ............................................................................................. 42 
7.7 
Severity Assessment ................................................................................... 43 
7.8 
Causality Assessment .................................................................................. 43 
7.9 
Exposure During Pregnancy ........................................................................ 44 
7.10 Withdrawal Due to Adverse Events .............................................................. 45 
7.11 Eliciting Adverse Event Information .............................................................. 45 
7.12 Reporting Requirements .............................................................................. 45 
 Serious Adverse Event Reporting Requirements .............................. 45 
 Non-Serious Adverse Event Reporting Requirements ...................... 46 
 Sponsor Reporting Requirements to Regulatory Authorities ............. 46 
8 
DATA MANAGEMENT ........................................................................................... 46 
8.1 
EDC System ................................................................................................ 46 
8.2 
Data Management Plan ............................................................................... 46 
8.3 
Conceptual Approach to Self-Selection ........................................................ 46 
8.4 
Classification Activities ................................................................................. 47 
 
Selection Decision ............................................................................ 47 
 
Appropriate to Use ........................................................................... 48 

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Physician Mitigation .......................................................................... 49 
 
Coding of Open-ended Responses ................................................... 50 
9 
DATA ANALYSIS/STATISTICAL METHODS ......................................................... 50 
9.1 
Sample Size Determination .......................................................................... 50 
9.2 
Analysis Populations .................................................................................... 51 
9.3 
Endpoint Analysis ........................................................................................ 52 
 
Primary Endpoint Analysis ................................................................ 52 
 
Target Thresholds ............................................................................ 53 
 
Secondary Endpoint Analysis ........................................................... 54 
 
Other Measures Analysis ................................................................. 57 
9.4 
Safety Analysis ............................................................................................ 58 
9.5 
Interim Analysis ........................................................................................... 58 
9.6 
Missing Data ................................................................................................ 58 
9.7 
Open-ended Data ........................................................................................ 58 
10 DATA HANDLING AND RECORD KEEPING ......................................................... 58 
10.1 Data Collection Instruments / Electronic Data Record .................................. 58 
10.2 Study Documentation ................................................................................... 59 
10.3 Confidentiality of Study Documents and Electronic Records ........................ 59 
11 QUALITY CONTROL AND QUALITY ASSURANCE .............................................. 59 
12 ETHICS .................................................................................................................. 60 
12.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ........ 60 
12.2 Ethical Conduct of the Study ........................................................................ 60 
12.3 Subject Information and Consent ................................................................. 61 
12.4 Liability and Insurance ................................................................................. 62 
12.5 Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
 
62 
12.6 Mandatory Reporting ................................................................................... 62 
13 SPONSOR DISCONTINUATION CRITERIA .......................................................... 63 
14 PUBLICATION OF STUDY RESULTS ................................................................... 63 
14.1 Communication of Results by the Sponsor................................................... 63 
15 EMERGENCY CONTACTS ................................................................................... 63 
16 STUDY DURATION AND DATES .......................................................................... 63 
17 REFERENCES ...................................................................................................... 64 
18 APPENDICES ........................................................................................................ 65 
18.1 Mock Package and Drug Facts Label ........................................................... 65 
18.2 Consumer Information Leaflet ...................................................................... 66 

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List of In-Text Tables and Figures 
 
Figure 1  Study Procedures Flowchart .......................................................................... 36 
 
Table 1  Endpoint Rationale for Primary and Secondary Endpoints ............................... 19 
Table 2 REALM Test Grade-Equivalent Reading Levels ............................................... 38 
Table 3 REALM-Teen Test Grade-Equivalent Reading Levels ...................................... 38 
Table 4 Self-Selection Decision Outcomes .................................................................... 47 
Table 5  Two-sided 95% CIs for Various Sample Sizes Around 85% Point Estimate ..... 51 

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1 
INTRODUCTION 
ella® (ulipristal acetate) is proposed for a prescription to over-the-counter (Rx-to-OTC) 
switch. This study is designed to assess whether consumers will use the product in a 
manner consistent with the labeling. A Drug Facts Label (DFL) for the nonprescription 
version of ella® has been drafted and evaluated in a pivotal label comprehension study 
(LCS). This protocol describes the next stage of the development program, a pivotal self-
selection (SS) and actual use trial (AUT), which will provide measures of how and when 
consumers select to use and use the product in an OTC-like setting. 
1.1 
Indication 
The proposed labeled “Purpose” for nonprescription ulipristal acetate 30 mg is 
“Emergency contraceptive.” The proposed labeled “Use” for nonprescription ulipristal 
acetate 30 mg is “for women to reduce chance of pregnancy after unprotected sex (if a 
contraceptive failed or if you did not use birth control).” 
1.2 
Background and Rationale 
This AUT is designed to demonstrate that consumers will select and use ella® in a 
manner consistent with the labeling.  
2 
STUDY OBJECTIVE AND ENDPOINTS 
2.1 
Objective 
The objective of this study is to evaluate the behavior of subjects in an OTC-like setting 
when selecting and using ella®. 
2.2 
Endpoints 
The determination of primary and secondary endpoints has been made based on the 
potential clinical consequences of a consumer failing to heed each key label instruction 
and the expressed concerns of the United States Food and Drug Administration (US 
FDA) about the potential for misuse of the product in an OTC setting. The rationale 
behind selection and prioritization of endpoints is summarized below in Section 2.3. The 
appropriateness of behaviors will be assessed by measuring the endpoints as per the 
endpoint analysis listed in Section 9.3. 
 
 Primary Endpoints 
A. Actual Use:  Proportion of dosing instances among user population taken within 
120 hours (5 days) of most recent episode of unprotected sex. 
B. Actual Use:  Proportion of dosing instances among user population in which no 
more than one tablet was taken. 
C. Self-Selection:  Proportion of female selectors who are not pregnant at the time 
of selection decision. 
 Secondary Endpoints 
D. Self-Selection:  Proportion of female selectors who are not breastfeeding at the 
time of selection decision 

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E. Self-Selection:  Proportion of self-selection population who make a correct 
selection decision. 
F. Actual Use:  Proportion of dosing instances among user population in which 
hormonal birth control (HBC) is not taken for 5 days after taking ella®. 
G. Actual Use:  Proportion of dosing instances among user population associated 
with use of hormonal contraceptives in the same cycle after taking ella® in which 
subject reports using a condom (or other barrier method) every time they have 
sex until their next menstrual period. 
H. Actual Use:  Proportion of user population who do not use the study product 
more than once in the same menstrual cycle. 
I. 
Self-Selection/Actual Use:  Proportion of self-selection population taking one of 
the “ask a doctor or pharmacist before use” products who do not select, who 
select but do not use or who report contacting a healthcare provider or 
pharmacist  
 
 Other Measures 
J. Actual Use:  Proportion of user population who used a HBC method sometime 
during the past two months. 
K. Actual Use:  Proportion of user population who used any emergency 
contraceptive (EC) on more than one occasion within the study period. 
L. Actual Use:  Proportion of user population who report becoming pregnant within 
the study period. 
2.3 
Rationale for Designation of Study Endpoints 
The determination of endpoints and designation as primary or secondary endpoints has 
been made based on the potential clinical consequences of a consumer failing to heed 
each key label instruction and FDA’s concerns regarding potential product misuse. Each 
endpoint is listed in Table 1 below, with the DFL messages relevant to the endpoint, 
followed by the rationale underlying the classification as a primary or secondary 
endpoint. Note that the “Other Measures” listed above in Section 2.2.3 are not 
endpoints. Rather, they are descriptive only, and will be used to help characterize the 
study population in the analysis. 
Table 1  Endpoint Rationale for Primary and Secondary Endpoints 
Endpoints 
Relevant DFL Message(s) 
 
 
Primary 
 
A 
Actual Use:  Proportion of dosing 
instances among user population taken 
within 120 hours (5 days) of most recent 
episode of unprotected sex.  
Directions: Take one tablet as soon as 
possible and no later than 120 hours (5 
days) after unprotected sex. 
 
 
 
 
Rationale:  The Sponsor proposes to test this message as a primary endpoint 
because it communicates directions for effective use of ella®, and the limited time-
window for its effective use. Use of ella® after 5 days diminishes the product’s 
efficacy, although it is not expected to introduce any drug-related risks. This 

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endpoint will allow confirmation that consumers do not take ella® later after 
unprotected intercourse than recommended in the product label. 
 
 
 
B 
Actual Use:  Proportion of dosing 
instances among user population in 
which no more than one tablet was 
taken. 
Directions: Do not take more than one 
tablet. 
 
 
 
 
Rationale:  The Sponsor proposes to test this message as a primary endpoint in 
the context of FDA’s recommendation to demonstrate in an AUT whether 
consumers misuse ella® with intake of more than the recommended dose.  This is 
proposed as a primary endpoint despite the fact that, while taking one tablet is 
essential to effectiveness of the product, dose-finding studies using up to 200 mg 
of ulipristal acetate (UPA) (more than 6 times the intended 30 mg dose) 
demonstrated no safety concerns (HRA2914-503), suggesting it is likely that 
taking more than the recommended dose is likely to impose little or no additional 
risk in women. 
 
 
 
C Self-Selection:  Proportion of female 
selectors who are not pregnant at the 
time of selection decision.  
Warnings: Do not use if you are already 
pregnant (because it will not work) 
 
 
 
 
Rationale:  The Sponsor proposes to test this message as a primary endpoint as it 
would allow the study to confirm that consumers do not select or take ella® if they 
are already pregnant, although the available safety data are reassuring for 
pregnant women exposed to ella®. 
 
 
 
 
 
 
Secondary 
 
D Self-Selection:  Proportion of female 
selectors who are not breastfeeding at 
the time of selection decision. 
Warnings: Do not use if you are 
breastfeeding 
 
 
 
 
Rationale:  While it has been shown that UPA and its metabolite are both excreted 
in breastmilk over the first 120 hours after administration, UPA is unlikely to have 
any detrimental effects on the newborn infant if ingested in breast milk, given the 
mechanism of action of UPA and the fact that there is no role for progesterone in 
the newborn infant. To date, no safety signal has been identified in newborns 
breastfed by women who have taken UPA 30mg.  
 
Because breastfeeding is not a contraindication for use of ella® in the prescription 
setting (though it is not recommended because of a lack of clinical data), this has 
been designated as a secondary endpoint in this AUT. 
 
 
 
E 
Self-Selection:  Proportion of self-
selection population who make a correct 
• 
Do not use if you are already 
pregnant 

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selection decision. 
• 
Do not use for regular birth control 
• 
Do not use more than once in the 
same menstrual cycle 
• 
Do not use if you are breastfeeding 
• 
Use: for women to reduce chance 
of pregnancy after unprotected sex  
• 
Allergy alert: Do not use if you have 
ever had an allergic reaction to any 
of the ingredients 
 
 
 
 
Rationale: The main goal of the AUT is to assess actual use of ella®. Given that 
potential clinical consequence of incorrect selection is unlikely to be serious, the 
Sponsor proposes to test correct self-selection of potential consumers as a 
secondary endpoint. 
 
 
 
F 
Actual Use:  Proportion of dosing 
instances among user population in 
which HBC is not taken for 5 days after 
taking ella®. 
Directions: After taking this product; 
users of birth control pills, patch or 
vaginal ring after use of this product: 
Do not use birth control pills, patch or 
vaginal ring for 5 days after taking this 
product. If you do, it may block the 
ability of both this product and your 
birth control to work. 
 
 
 
 
Rationale: The concern about starting HBC within 5 days after taking ella® relates 
to a theoretical decrease in the efficacy of ella® resulting from an interaction 
between ella® and progestins in HBC products. In reality it is uncertain to what 
extent the efficacy of ella® is affected or, indeed whether it is affected at all.  
The recommendation to delay starting HBC after taking ella® stems from a single 
study by Brache et al published in 20153. The study was designed to explore a 
possible interaction between ella® and HBC, when HBC was started immediately 
after taking ella®. It was a small study of just 49 women who were not using HBC 
prior to using ella®, and who took ella® when an ovarian follicle had reached at 
least 14 mm in diameter and so were soon to ovulate; that is, at the point in the 
menstrual cycle when ovulation was already most likely to occur. The following 
day, half of the women started an HBC (a progestin-only pill, POP) while the 
others started a placebo. The key finding was that 44% of women who started 
HBC ovulated within 5 days of taking ella® while only 10% of women in the 
placebo group ovulated in that time frame. Notably, over 50% of women who 
started HBC after ella® did not ovulate and so were not at risk of pregnancy. 
Nevertheless, the theoretical concern was that starting HBC immediately after 
ella® use might reduce the efficacy of ella®. 
This was a small pharmacodynamic study of just 49 women, and the 
recommendation to delay the start or restart of HBC is based on observing just 11 
women ovulating. Most importantly, the study was not designed with pregnancy as 

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an endpoint. Nevertheless, the Sponsor took a conservative and cautious position 
in changing the prescription ella® label to reflect this theoretical concern, hence 
the advice to wait 5 days before starting or restarting HBC. However, because of 
all the limitations of the Brache study, the medical community cannot agree 
whether or not this recommendation is important. In Europe, this instruction has 
not been added to the ella® label and the failure rate of ella® remains low. 
The situation pertaining to use of ella® followed by HBC under OTC conditions is 
different. In the Brache study, the women had not taken HBC prior to using ella® 
and they took ella® in the presence of a large pre-ovulatory follicle, i.e., on the 
verge of ovulating. In the OTC situation, the recommendation to delay starting 
HBC applies only to women who have already been taking HBC prior to using 
ella® (since to acquire a new supply of HBC will require a prescription). Thus these 
ella® users are likely to be women who are seeking EC because they have missed 
pills. Unlike the women in the Brache study, these women are at very low risk of 
pregnancy. HBC use suppresses ovarian activity and it takes time for the ovary to 
recover when the pill is stopped. In a Cochrane review of the effect of missed pills 
on fertility, Zapata et al4 reviewed a number of pharmacodynamic studies in which 
pills were deliberately missed. They concluded that even after missing up to 14 
days of HBC (pills) ovulation is uncommon. In 207 women who missed pills for 
between 8 and 11 days, there were no ovulations and in women who did ovulate 
(usually following missed pills for longer intervals) the cycle was not normal, 
follicles were small, progesterone levels were low and cervical mucus hostile.  
So, in conclusion, if a woman buys ella® over the counter and has a supply of 
HBC, which she wants to restart after ella® use, should she fail to follow the 
instructions to delay restarting HBC, she is highly unlikely to get pregnant. 
Accordingly, the Sponsor proposes that the percentage of women who delay 
re/start of the HBC for 5 days after ella® intake be a secondary endpoint in this 
study. 
 
 
 
G Actual Use:  Proportion of dosing 
instances among user population 
associated with use of hormonal 
contraceptives in the same cycle after 
taking ella® in which subject reports 
using a condom (or other barrier 
method) every time they have sex until 
their next menstrual period. 
Directions: After taking this product; 
users of birth control pills, patch or 
vaginal ring after use of this product: 
Use condoms (or another barrier 
method) every time you have sex until 
your next menstrual period.  
 
 
 
 
Rationale: This secondary endpoint is intended to address the hypothetical risk of 
pregnancy resulting from unprotected intercourse after use of ella® due to the 
potential risk of delayed ovulation in users of hormonal contraceptives. However, 
as described above in Secondary Endpoint F, risk of pregnancy for these women 
is minimal, and therefore this endpoint is also designated a secondary endpoint in 
this AUT. While women who start HBC with a 5-day delay can further decrease 
the slim chance of pregnancy from an act of unprotected sex in that short interval 

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by using condoms, once again, this was a very cautious position since the chance 
of pregnancy in that interval, even without use of a condom, is extremely low. 
Furthermore, all women (not just those starting/restarting HBC after ella® use) 
having unprotected sex after using any method of EC (i.e., ella® or EC containing 
LNG including Plan B) and before their next menses should ideally use condoms 
as back up to reduce the risk of pregnancy, but labeling to that effect is not 
present on other EC products in the OTC marketplace. 
 
 
 
H Actual Use:  Proportion of user 
population who use the study product 
more than once in the same menstrual 
cycle. 
Directions: Do not use more than once 
in the same menstrual cycle. 
 
 
 
 
Rationale: While data has been collected that demonstrates that using ella® more 
than once during a menstrual cycle does not pose any safety risk, the direction not 
to use ella® more than once in a menstrual cycle is still on the prescribing 
information. For this reason, as well as feedback from the FDA, this will therefore 
be tested as a secondary endpoint.  
 
 
 
I 
Self-Selection/Actual Use:  Proportion of 
self-selection population taking one of 
the “ask a doctor or pharmacist before 
use” products who do not select, who 
select but do not use or who report 
contacting a healthcare provider or 
pharmacist 
Consumer Information Leaflet:   
 
Talk to a healthcare professional 
or your pharmacist before taking ella® 
if you are taking certain drugs to treat: 
• 
seizures (barbiturates, 
carbamazepine, felbamate, 
oxcarbazepine, phenytoin, 
topiramate) 
• 
tuberculosis (rifampin) 
• 
fungal infections (griseofulvin) 
• 
HIV or AIDS 
• 
pulmonary hypertension (bosentan) 
• 
St. John’s Wort (or any herbal 
products containing hypericum 
perforatum) 
 
 
 
 
Rationale: In vitro studies indicate that ella® is predominantly metabolized by 
CYP3A4, suggesting that CYP3A4 inducers may decrease the plasma 
concentration of ella® if administered concomitantly, as it was shown with 
rifampicin. However, no clinical studies have demonstrated a potential increased 
risk of pregnancy among women treated with CYP3A4 inducers and there is no 
data indicating that increasing the dose of UPA may have an impact on a 
theoretical risk of pregnancy.  Additionally, similar drug-drug interactions exist for 
levonorgestrel and CYP3A4 inducers, the only other readily available option for 
emergency contraception. 
Unintended pregnancy is particularly undesirable in women taking many of these 
drugs since they are used to treat serious conditions many of which pose 
significant risks to the fetus.  ella® is not contraindicated in these circumstances, 
rather the potential concern is that emergency contraception (including 

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levonorgestrel) may be less effective if used with concomitant medication.  An 
emergency contraceptive which may be slightly less effective is arguably 
preferable to no emergency contraception for this particular group of women. 
Given that the clinical impact of concomitant use of a CYP3A4 inducer with ella® 
use is unclear, that there are no recommendations precluding the use of ella® 
under these circumstances, and that the only other available option for oral EC 
has similar interactions (despite no drug interactions listed in the OTC labeling), 
this endpoint is designated as secondary. 
 
3 
STUDY DESIGN 
This is an observational open-label, multicenter, 6-week study designed to create as 
much as possible an OTC-like environment in which subjects will make a self-selection 
and purchase decision about ella® based only on their reading of the outside of the 
package including the DFL. Qualified subjects who choose to purchase the study 
medication will do so, then leave the study site and use the product on their own. The 
study is designed to assess if, when and how subjects use the medication in an OTC-like 
environment. 
It is important to note that subject characteristics and how they might be related to 
behaviors directed by the DFL that are gathered at screening, enrollment, or during the 
6-week study period will not be discussed directly with subjects until the end of study 
interview. 
3.1 
Naturalistic Design 
This trial is a multi-center trial conducted in a naturalistic environment. Study 
characteristics and procedures were designed to make it as naturalistic as possible. 
Some of the key naturalistic elements include the following: 
• 
There are minimal study exclusionary criteria imposed on subjects, making this 
trial nearly an all-comers study to mimic the likely OTC population. 
• 
The study will be conducted in women’s health clinics and pharmacies, 
representing typical locations where consumers now commonly purchase EC in 
an OTC-like setting. 
• 
The proposed OTC packaging and labeling is the only product information 
provided to subjects during the study. Subjects will only review the outer 
packaging at the initial visit. Study staff will not provide any additional information 
or encouragement regarding product selection at that visit. Staff will not answer 
subject questions but will redirect them to the outer package. 
• 
After purchasing the study product, subjects will take the package with them 
when they leave the site; the package will include the outer packaging and, inside 
the package, the consumer information leaflet (CIL) and study medication. 

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3.2 
Study Sites 
Approximately 25 women’s health clinics and 10 retail pharmacies will be chosen for this 
study as they provide an environment that is considered typical of those from which 
consumers may expect to find this product following approval, and which represent the 
places women currently go to seek EC in an OTC-like setting. The women’s health 
clinics sell currently available OTC EC in an OTC-like manner without the requirement to 
see a clinician. These clinics typically have a window or a front desk area where women 
purchase EC by requesting it from non-clinical staff, in a manner similar to consumers 
purchasing an OTC product in a pharmacy. 
Study sites will be selected to provide geographic and demographic diversity. They will 
be selected from approximately eight geographic regions in the US. Each site has a 
private office or a suitable semi-private area where the study will be carried out privately 
and without distraction. The study area will also have all of the necessary computer 
equipment and a high-speed Internet connection to accommodate the electronic data 
capture system (EDC). 
It is expected that subjects enrolled through health centers are likely to be younger on 
average and have higher prevalence of low literacy than subjects who might respond to 
recruitment for a more typical AUT.  
 Site Training and Procedural Integrity 
PEGUS Research will select sites and train the site staff after approval by the Sponsor 
and the Institutional Review Board (IRB). All study staff will receive study-specific 
training. All training will be documented and retained in the study files. 
3.3 
Subject Selection 
Actual use trials are designed to determine how well the general population of 
consumers is able to apply the information in nonprescription drug labeling to guide their 
own behavior. Subjects should therefore represent a wide range of demographic 
characteristics. 
In order to mimic the OTC marketplace as much as possible, subject selection will be 
self-driven by response to an invitation to participate in the study issued at the point of 
sale for women seeking EC.  In general, that will mean intercepting women who are self-
pay or who are willing to be self-pay for the purposes of the study, and who present for 
EC only. Consumers who are purchasing EC for someone else’s use will not be invited 
to participate, as they cannot give consent on behalf of the actual user. 
Given that adolescents are an important subgroup in the study, adult subjects will be 
constrained to no more than 775 subjects, allowing for an adolescent subgroup number 
of approximately 175. Further, the group of older adolescents (age 15 and older) will be 
constrained to 125, to allow for approximately 50 subjects under the age of 15. If 
adolescent recruitment lags significantly behind adult enrollment, as a backup 
recruitment method, clinicians within the health center will be allowed to invite 
adolescents to participate in the study if the subject identifies a need for EC in the 
context of a clinical visit. In those cases, clinicians will not instruct subjects how to use 

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the study product; they will simply acknowledge the need for EC and extend the 
invitation to participate. 
While it is unusual in an actual use trial to allow for active recruitment on the part of 
clinicians, the FDA-requested goals for adolescent enrollment are very likely to make 
supplemental recruitment measures necessary, particularly for those under age 15. 
Should recruitment via clinicians for adolescent subjects be necessary, in order to 
minimize the potential for bias, clinicians will be trained not to counsel potential 
adolescent subjects about the use of EC in general, nor will they give specific counseling 
about the study product. This supplemental mechanism of recruitment, if used because 
needed to meet adolescent recruitment goals, is unlikely to have any impact on the 
primary endpoints of the study. The usual concern about active clinician recruitment is 
that it may bias self-selection. There are three factors to consider regarding this 
theoretical concern. First, consumers’ ability to self-select for emergency contraception 
as a whole in the OTC market has already been established. Second, self-selection for 
this product is very similar to already available OTC emergency contraceptives. Third, 
any potential bias affecting self-selection would be in the negative direction as subjects 
may indeed select the product mistakenly thinking that the clinician has recommended it, 
when, in fact, the product is not right for them. In order to estimate any impact of clinician 
referral on self-selection endpoints, data will be presented separately for adolescent 
subjects recruited in this manner. 
 Inclusion Criteria: Self-Selection Phase 
In order to enroll a sample as representative as possible of the likely OTC consumer, the 
study inclusion criteria are defined as broadly as it is feasible. Subjects must meet the 
following initial screening inclusion criteria in order to begin the enrollment interview:  
1. Able to read, speak and understand English  
2. Can see well enough to read information on the label  
3. Another member of the respondent’s family has not participated in this study 
4. Consumer or someone else in the household does not work for a market 
research or advertising company, public relations firm, news organization, 
pharmacy or pharmaceutical company, medicine manufacturer, as a healthcare 
professional, or as part of a health care practice, managed care or health 
insurance company, trained or worked as a healthcare professional or market 
research professional (eliminated for reasons of confidentiality and increased 
awareness of medicines and their labels) 
5. Has not participated in a health-related market research or product label study in 
the past 12 months 
6. Has not participated in a clinical trial in the past 12 months 
7. Has never participated in a study about EC 
8. Seeking the use of emergency contraception 

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Additionally, subjects must meet all of the following inclusion criteria to be eligible for 
enrollment into the use phase of the study: 
• 
Evidence of a personally signed and dated informed consent form indicating that 
the subject (or a legal representative) has been informed of all pertinent aspects 
of the study. 
• 
Willing and able to comply with the initial visit and planned phone calls and other 
study procedures. 
 Exclusion Criteria: Use Phase 
All subjects who agree to participate at the site will be asked to make a selection 
decision. Subjects presenting with any of the following will not be included in the use 
phase of the study (i.e., will not be allowed to purchase and use study medication): 
1. Unwilling to purchase study medication. 
2. Unwilling to provide written informed consent. 
3. Unwilling or unable to provide contact information. 
4. Unwilling to state that the product is for their own use and no one else’s. 
5. Pregnant, by self-report or by a urine pregnancy test. 
6. Male. 
7. Known allergy to ulipristal acetate or inactive ingredients. 
8. Currently breastfeeding. 
9. Premenarchal (have not experienced a first menstrual cycle). 
Subject eligibility will be reviewed and documented by the Investigator or his/her 
designee before subjects are allowed to purchase and begin the use phase of the study. 
 Recruitment Methods 
The nature of the indication (emergency contraception) makes recruitment for the trial 
challenging. By definition a woman does not know in advance that she will need EC, and 
when she does need it (because she has had unprotected sex), she needs it quickly. 
Therefore, a passive advertising campaign aimed at consumers interested in the 
indication (the approach typically used in AUTs) is unlikely to be effective for this study. 
Similarly, it would be inappropriate to make a woman who has had unprotected sex and 
is in need of EC as soon as possible wait for a scheduled appointment at the study site 
and potentially delay her taking the EC that she needs to take within a limited timeframe. 
This is particularly true because an approved OTC option is available to her outside the 
study. 
Therefore, subjects will be actively recruited at the point of OTC-like sale in women’s 
health clinics and in the retail pharmacy study sites. Sites which currently sell EC in an 
OTC or OTC-like setting and which have enough EC sales to meet recruitment goals will 
be chosen. They will also be chosen to ensure geographic and demographic diversity, 
and to be as representative of literacy in the general population as possible. When a 
subject presents asking for EC, they will be offered the opportunity to participate in the 

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study. Additionally, posters advertising the study may be placed strategically within the 
sites to attract potential subjects who are there considering a purchase of EC. In the 
event that adolescent recruitment significantly lags behind adult recruitment, as a 
supplementary method of recruitment, clinicians within the health centers will be allowed 
to invite adolescent subjects who, during the course of a clinical visit, have identified the 
need for EC. In those cases, the clinician will be instructed not to give instructions on 
how EC generally or the product specifically is to be used. Potential subjects recruited in 
this way then will be routed to the study staff for the face-to-face enrollment interview. 
See Section 3.3 for more information.  
3.4 
Randomization 
There is no randomization in this study. 
3.5 
Data Collection 
Data will be collected in structured one-on-one interviews using a standardized 
questionnaire either in-person (at the initial enrollment visit) or by telephone (in two 
follow-up interviews). The interviews will be administered by a trained interviewer using 
an internet-based Electronic Data Capture (EDC) application in which the interviewer will 
read the introductory scripts and the questions from the screen and will enter the 
responses directly into the study database. As a precaution, a paper version of the 
questionnaire will be available at each site should there be a loss of internet connection 
while using the EDC system during the course of an interview. This will allow the 
interviewer to complete the enrollment process for that subject; interviews will not be 
started on a paper DCI. Data from any interviews completed on paper will be entered 
into the EDC system as soon as possible after access is restored, and the paper 
questionnaires will be retained as source documents in the study files. 
The questionnaires will include primarily open-ended questions. Question types will 
include direct questions and follow-up questions for clarification. No multiple-choice 
questions will be used. To facilitate the accurate capture of responses, open-ended 
questions will have pre-coded answer alternatives. It is important to note that these 
response alternatives will not be read to the subjects, nor will subjects be able to see 
them on the screen. Where close-ended questions are used (e.g., yes/no, or ok/not ok), 
subjects will be asked to explain their answers so behavior can be adequately assessed. 
When interviewers must type in open-ended question responses, they will capture short 
responses verbatim, and will accurately summarize longer responses.  
During the self-selection interview at the initial visit, the ella® outer package including 
DFL will remain in front of the subject and the subject will be informed they can refer to 
the label at any time. However, the subject will neither be encouraged nor discouraged 
from referring to the package in response to any specific question. 
All data will be collected via standardized, predesigned questionnaires in a one-on-one 
setting either in person or by telephone. For this study, no daily diary will be used. In the 
context of an AUT, a daily diary has the potential to influence subject behavior, making it 
much less naturalistic. In the case of a daily or frequent use medication, the advantages 
of a diary for the purposes of measuring the key endpoints may outweigh those 

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disadvantages. However, in the context of a single use product for EC, subject recall of 
when they took the product relative to unprotected sex and/or enrollment is expected to 
be quite good, as it is a singular, unique event with strong anchoring to context and 
timeline. 
3.6 
Test Materials 
At the initial site visit, subjects will be provided with an empty ella® package that will 
display the proposed DFL (Appendix 18.1); they will review that package/box when 
making a self-selection and purchase decision.  
The product purchased and taken home for use will include the exact same outer 
package, but the study medication and a CIL will be in the package. 
Subjects who enter the use phase will also be provided with an administrative study 
information card (to include subject number, the central telephone number for any 
inquiries and direction to call to report any changes in health [AEs] experienced during 
the study). The administrative study information card will serve as a memory tool for 
subjects, and will not be returned to PEGUS. Subjects will also receive a self-
administered urine pregnancy test to use at the end of the study and a pre-paid envelope 
to mail back unused study product or empty packaging. 
3.7 
Study Administrative Structure 
Laboratoire HRA Pharma is the Sponsor for this study. PEGUS Research is the contract 
research organization (CRO) responsible for the development of the study materials, 
training interviewers, fielding of the study, coding of open-ended responses, analysis of 
the data, and preparation of the study report. 
4 
STUDY TREATMENTS 
4.1 
Allocation to Treatment 
All subjects enrolled in the use phase of this open-label study will be given the 
opportunity to purchase and take 30 mg of ulipristal acetate. 
4.2 
Breaking the Blind 
Not applicable to this study. 
4.3 
Drug Supplies 
 Formulation and Packaging 
Tablets for oral administration contain 30 mg ulipristal acetate and the following inactive 
ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and 
povidone. 
ella® is available as a 30 mg tablet, packaged in a carton containing a blister card with a 
single tablet, constituting one dose. 

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 Preparation and Dispensing 
All subjects who use study medication will take ulipristal acetate 30 mg. Subjects are to 
use the investigational product (IP) based on their understanding of the directions on the 
outer packaging including DFL and inside the product packaging (in the CIL). 
Subjects will be allowed to purchase the study product at the study site. Subjects will not 
be allowed to purchase more than 9 single-count packages during the entire study 
period. They will be allowed to purchase up to 3 packages at a time (on any one 
calendar day) during their first visit to the site and may return to the study site at any 
time to purchase additional medication, up to a total of 9 packages, during the following 
6 weeks. These purchase limits will not be disclosed to subjects unless they try to 
purchase more than 3 packages in a day or more than 9 packages over the course of 
the study. Any such requests that exceed the purchase limits will be recorded. 
It is typical to allow participants in an actual use trial to purchase more IP than they 
would use under usual conditions, in order to allow for the observation and 
measurement of overuse/misuse of the product, should it occur. In this case, as there is 
no true “typical use” for EC because the product is used under unusual circumstances 
(in instances of unprotected sex), purchase limits were chosen to allow for reasonable 
behavior on the part of subjects, even if beyond the label directions, without allowing for 
larger scale misuse. While the expectation is that the vast majority of subjects will 
purchase a single package of the IP, it would be reasonable for subjects to purchase 
additional doses for advance provision. The daily limit was set at three to account for 
this. Again, while the expectation is that very few subjects will return for resupply, in 
order to observe overuse or misuse should it occur, repurchase will be allowed. Indeed, 
given FDA’s expressed concern about the potential for misuse of this product, in 
previous interactions FDA agreed with the planned purchase limits as these limits would 
allow the AUT to estimate the likelihood of potential misuse when the product is 
available OTC. 
 Drug Storage and Accountability 
The Investigator will ensure that the IP is stored under recommended storage conditions 
at the site and in accordance with the drug label (store at controlled room temperature 
20°C to 25°C [68°F to 77°F]; see United States Pharmacopeia [USP]). 
The IP must be stored as indicated on the package. Deviations from the storage 
requirements, including any actions taken, must be documented and reported to the 
monitor by the sites. Deviations outside of the range of 20°C to 25°C [68°F to 77°F], but 
between 15°C and 30°C [59°F and 86°F], will be documented and reported to the 
Sponsor by the monitors and IP will continue to be used. If a deviation is identified 
outside of the range 15°C to 30°C [59°F to 86°F], the deviation must be reported upon 
discovery and the IP must be quarantined and not used until the Sponsor provides 
documentation of permission to use the IP. The Investigator must maintain adequate 
records documenting the receipt, use, loss, or other disposition of the IP(s). 
At the end of the trial, subjects will be asked to return any unused study medication and 
empty packaging. Subjects will be provided with a pre-paid, pre-addressed United States 
Postal Service envelope to send any unused study medication and empty packaging to 

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PEGUS Research. If PEGUS Research has not received the return unused medication 
or empty packaging within three business weeks after the subject exits the study, one 
follow-up telephone call will be placed requesting that the subject return any unused 
study medication and empty packaging. 
The Sponsor will provide instructions as to disposition of any unused and returned IP.  
4.4 
Drug Administration 
Subjects who use the IP are to use it based on their understanding of the labeling. 
Because use of the IP is not driven by protocol, there are no medication errors involving 
subject exposure to the IP, though there may be potential medication errors or uses 
outside of what is foreseen in the protocol that do or do not involve the participating 
subject. Any such medication error will be reported to the HRA pharmacovigilance (PV) 
department. If applicable, any associated adverse event(s) (AE(s)) will be documented 
via the mechanism for spontaneous AE reports. 
 Compliance 
There is no protocol-directed use of the study product and subjects will use the product 
at their own discretion based on their understanding of the DFL and other material on or 
in the package. The subjects will report on their use of the product in the two follow-up 
telephone interview(s). 
4.5 
Concomitant Medication(s) 
The IP packaging (the CIL) will contain information about the use of other medications 
when taking ella®. Subjects will be queried at enrollment about medications that they are 
currently taking. During the two study telephone interviews, subjects will be queried about 
any new medications that they have begun taking since the start of the study. 
4.6 
Rescue/Escape/Salvage Therapy 
Not applicable for this study. 
4.7 
Batch Recall 
In case a batch recall is required during the course of this protocol, site monitors will be 
responsible for communicating with research sites and for organizing and following-up on 
the logistics of the recall, in collaboration with the sponsor and research sites.   
At the end of the process, the site monitors will ensure that the total number of IPs 
returned to the PEGUS matches the total number of IPs delivered to all sites. Any 
discrepancy must be explained. 
5 
STUDY PROCEDURES 
5.1 
Pre-Interview Activities 
Potential subjects who spontaneously present to one of the study sites seeking EC in an 
OTC or OTC-like setting will be invited by clinic or pharmacy staff to participate in the 

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study. Potential subjects who are interested will be immediately routed to study staff 
trained to do the enrollment procedures. 
5.2 
Study Period 
 Enrollment Visit, Self-Selection/Purchase Decision 
At the enrollment/self-selection visit (constituting Study Day 1), which takes places at the 
women’s health clinic or pharmacy, initial inclusion criteria will be reviewed and potential 
subjects will be shown the ella® package and given as much time as needed to review the 
information on the outer package. After reviewing the outer package, they will be asked 
whether the product is okay or not okay for them to use and if they want to purchase the 
product for their own use. Reasons for selection/non-selection and purchase/non-
purchase will be recorded. 
 After Purchase Decision and Before Use Phase 
The purpose of this study is to see how the subject complies with the labeled directions; 
therefore, the date of the use of study medication is determined by the subject. Study Day 
1 will be defined as the day the product is dispensed to the subject. On Study Day 1, 
subjects will complete the enrollment interview including associated medical conditions 
and demographic information. Subjects will also be asked to complete the REALM1 or 
REALM-Teen2 test to establish reading ability. 
Study exclusion criteria will be assessed and only qualified subjects who decide to 
purchase the product will continue on to the study use phase. Subjects will provide 
informed consent. Parental consent and subject assent will be obtained where required 
based on applicable local laws and regulations. See Section 12.3 for further information 
on parental consent of adolescent subjects. 
After consent, all subjects will provide a urine sample for the study staff member to 
conduct a urine-based dip pregnancy test.  Subjects with a positive pregnancy test will be 
asked to make a selection and purchase decision again with the new information 
regarding pregnancy and then excluded from the use phase of the study.  
Qualified subjects will be required to provide contact information (for the purposes of 
conducting telephone follow-up interviews) and information regarding any medications 
they are currently using. Subjects who choose to will then purchase the IP and site study 
staff will complete the electronic product accountability form. While it is expected that 
most subjects will purchase a single package of ella®, subjects will be allowed to 
purchase up to 3 boxes in any one day, and will be allowed to return to the study site at 
any time during the use phase to purchase additional medication. Subjects will not be 
allowed to purchase more than 3 single dose packages in a single day, or more than 9 
single-dose packages during the study period although this will not be communicated to 
the subjects unless they attempt to purchase more than that. Any requests for purchase 
more than the limits will be recorded. 
Subjects will also be informed that study and End-of-Study (EOS) phone interviews will 
be conducted at Week 2/Day 14 (with an allowable window of ±3 days) and at Week 
6/Day 42 (±4 days). Subjects who have purchased the product will be dispensed the 
product to use how and when they see fit. 

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Subjects also will be provided with a self-administered urine pregnancy test and given 
instructions to use the test at the end of the study period. Results will be recorded in the 
database in the End-of-Study interview. 
5.3 
Use Phase 
 Unscheduled Study Site Visits 
During any unscheduled visit to a study site for purposes of subjects obtaining additional 
IP, the study staff contact with the subjects will be limited to: 
1. Dispensing additional IP with no questions asked or answered or directions given 
about the use of the IP by the study staff. 
2. Appropriately documenting the IP dispensed. 
3. Assisting any subject presenting self-reported AEs by immediately having the 
subject contact PEGUS Research. 
 Telephone Interviews 
The two scheduled phone interviews will be conducted by PEGUS Research clinical staff 
(usually nurses) to collect information regarding AEs and concomitant medications. 
During the 6 weeks of the study, subjects will be contacted by phone on Days 14 (with an 
allowable window of ±3 days) and 42 (±4 days) to answer phone interview questions and 
provide information on AEs and concomitant medication (and, in the end of study 
interview, about pregnancy test results). 
In addition, several non-leading questions will be asked about behavior at the two phone 
interviews. Information will be asked for during both phone interviews in a masked 
manner to avoid influencing future behavior (e.g., “Besides taking the medication, is there 
anything else you have done to prevent pregnancy since we last spoke?”). 
Subjects will be compensated for their time and effort to enroll and participate in the study 
at designated intervals during the study. 
5.3.2.1 Week 2 Interview  
The intent of the week 2 interview is to collect information about the initial use of the 
product. Because subjects in this study will be invited to participate after independently 
presenting to the clinic or the pharmacy seeking EC (and not in response to advertising), it 
is expected that most subjects will be purchasing EC for immediate use (because they 
have very recently had an episode of unprotected sex), rather than solely for advanced 
provision. The interview at 2 weeks is intended to ascertain whether the subject took the 
IP, and if so, to collect information about when she took ella® in relation to her enrollment 
visit (and in relation to their most recent episode of unprotected sex) and measure other 
behaviors in the period immediately surrounding taking the product. Timing of this 
interview is expected to be long enough after enrollment to allow for capturing of use 
within or outside of the 5-day window and resumption or starting of hormonal 
contraception use in the 5 or more days after ella® intake, but also to be soon enough that 
recall should not be problematic. Information about AEs and changes to concomitant 
medications will also be collected. 

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5.3.2.2 Week 6 Interview  
Timing of the Week 6 interview is intended to allow for most women to have had at least 
one menstrual period after enrollment. Questions will be designed to collect information 
about behaviors related to EC use outside of the immediate period after use, as well as 
responses to a missed period. Information about AEs and changes to concomitant 
medications will also be collected. 
5.3.2.3 End-of-Study Interview 
In most cases, the EOS interview will take place in conjunction with the 6-week telephone 
call together with the week 6 interview. However, it is conceptualized as a separate 
interview in order to allow for collection of key end of study measures in cases where 
subjects elect to withdraw before the 6-week telephone call. The end-of-study interview 
will collect information from the subject regarding the use of other forms of 
contraception, including other uses of EC (if any) within the study period, and the timing 
of such use. Subjects will also be asked about possible pregnancy, and will be asked to 
report the results of their EOS pregnancy test. This interview allows for direct questions 
about the rationale behind any behaviors that are not consistent with the DFL and CIL, 
without concern about biasing the subject's subsequent behavior. 
5.4 
Subject Withdrawal (Early Termination) 
An EOS interview will be conducted with any subject who discontinues or withdraws 
consent prior to Week 6, unless the subject withdraws consent for disclosure of future 
information. This interview will attempt to collect the EOS information and the reasons for 
the subject’s early termination. If the subject withdraws from the study between days 1 
and 17 (day 14+3), the clinical interviewer will attempt to complete the Week 2 and EOS 
interviews and gather EOS pregnancy test results. If the subject withdraws between days 
17 and 46 (day 42+4), the clinical interviewer will attempt to complete the Week 6 and 
EOS interviews and gather EOS pregnancy test results. See Sections 6.4, 6.5, and 6.6 
for more detailed information on the interviews. 
Subject participation may be terminated by an investigator during the study for any of the 
following reasons: 
• 
Significant protocol violation; 
• 
AEs, including SAEs; 
• 
Pregnancy; 
• 
Physician decision; 
• 
Subject’s request; 
• 
At the discretion of the Investigator or designee if s/he feels that study 
discontinuation is necessary to protect the subject, or that there are 
unmanageable factors that will interfere significantly with the study procedures 
and/or the interpretation of results. 
Any such subjects will be asked to return any unused study medication and empty 
packaging and will be precluded from purchasing additional study medication, but earlier 

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collected data will be used and ongoing data collection will be allowed, unless the subject 
requests otherwise. 
Subjects may withdraw from the trial at any time at their own request, or they may be 
withdrawn at any time at the discretion of the Investigator or Sponsor (or Sponsor 
designee) for safety or behavioral reasons, or the inability of the subject to comply with 
the protocol required schedule of study visits or procedures at a given study site. 
If a subject refuses contact for scheduled follow-up calls, any efforts made to contact the 
subject will be documented. In any circumstance, every effort will be made to document 
subject outcome, if possible. The investigator will inquire about the reason for withdrawal, 
request the subject to return all unused IP(s) and empty packaging, request the subject to 
participate in a final telephone interview, if applicable, and follow up with the subject 
regarding any unresolved adverse events (AEs). 
If the subject withdraws from the study, and also withdraws consent for disclosure of 
future information, no further evaluations will be performed, and no additional data will be 
collected. The Sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
A subject may be declared lost to follow-up if, during the study, the available contact 
information is determined to be incorrect and no other information is available. Every 
attempt will be made to contact lost to follow-up subjects, including three phone call 
attempts and a United States Postal Service (USPS) letter. Subjects whose status is 
withdrawn, lost to follow-up, withdrawal due to an AE or withdrawal from the study for 
other reasons will be recorded in the case report form (CRF). 
If a subject wishes to discontinue his or her participation in the study, the 
Investigator/interviewer will document the reason for withdrawal, ask the EOS questions 
where possible and follow-up with the subject regarding any new or unresolved AEs and 
collect or make arrangements to collect all IP provided to the subject. Data collected up to 
the point of withdrawal will be retained and used as appropriate in the data analysis. 
 
 

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5.5 
Study Flow 
Study procedures are represented in a flow chart in Figure 1 below. 
Figure 1  Study Procedures Flowchart 

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6 
ASSESSMENTS 
Every effort will be made to ensure that the protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time, there may be 
circumstances outside of the control of the Investigator that may make it unfeasible to 
perform the test. In these cases, the Investigator will take all steps necessary to ensure 
the safety and well-being of the subject. When a protocol required test cannot be 
performed, the Investigator will document the reason for this and any corrective and 
preventive actions which he/she has taken to ensure that normal processes are adhered 
to as soon as possible. 
The study team will be informed of these incidents in a timely fashion. All data will be 
collected using an Electronic Data Capture Data Collection Instrument (DCI). 
6.1 
Screening Assessment 
Subjects will be screened during the initial visit to determine those individuals who will be 
included or excluded from the trial.  
6.2 
Enrollment Interview 
Subjects will be shown the ella® outer package and allowed to make a decision about 
whether the product is appropriate for them to use, and whether to purchase ella® for their 
own use. Subsequent questions will be asked to gather limited medical and medication 
history as it pertains to use of the product.  
6.3 
Reading Level Assessment 
The REALM1 (for adults) or the REALM-Teen2 (for adolescents) test will be used to 
measure reading grade level and will be the measure of literacy used for this study. The 
REALM score corresponds to four grade-equivalent reading levels as shown in Table 2 
below, while the REALM-Teen score corresponds to 5 grade-equivalent reading levels as 
shown in Table 3 below. A REALM score of 60 or less (a reading level of 8th grade or 
lower) defines the low literacy subgroup among adult subjects. 
The REALM-Teen test does not have a 9th grade reading level cutoff, so a cutoff score of 
60 or lower will be used to define the low literacy cohort for the adolescent group as well 
(which is the midpoint of the 8th - 9th grade-equivalent reading level). This allows for a 
somewhat more conservative requirement to be classified as low literacy among the 
adolescent cohort in comparison to the cutoff for 10th grade-equivalent reading level. 
The REALM-Teen will be used to demonstrate (along with demographics) that adolescent 
subjects represent a diversity of age, race, educational attainment, and reading ability. 
However, given the relatively small absolute number of low literacy adolescents expected 
(if 25% of the sample of 175 adolescents meet the criteria, this would yield approximately 
44 low-literacy adolescents), low literacy adolescents will be included with low literacy 
adult subjects to comprise the overall low literacy subgroup. 
 
 

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Table 2 REALM Test Grade-Equivalent Reading Levels 
 
REALM1 Score 
Grade-equivalent 
Reading Level 
Included as 
Low-literacy 
Included as 
Normal-literacy 
0-18 
3rd 
X 
 
19-44 
4th to 6th 
X 
 
45-60 
7th to 8th 
X 
 
61-66 
9th and above 
 
X 
Table 3 REALM-Teen Test Grade-Equivalent Reading Levels 
REALM-Teen2 
Score 
Grade-equivalent 
Reading Level 
Included as  
Low-literacy 
Included as  
Normal-literacy 
0-37 
3rd 
X 
 
38-47 
4th - 5th 
X 
 
48-58 
6th - 7th 
X 
 
59-62 
8th - 9th 
≤ 60 
≥ 61 
63-66 
10th and above 
 
X 
 
Given that literacy (as measured by the REALM or REALM-Teen) is not known in 
advance and cannot be directly used in screening in an actual use trial, recruitment 
targets for low literacy are not set. In self-selection and actual use studies that recruit in 
the typical manner, the proportion of low literacy subjects typically ranges from 12-18%. 
In contrast with label comprehension studies, whose samples are meant to be 
approximately representative of the general population and therefore controlling for 
factors of interest like literacy is potentially justified, one of the overarching goals of an 
actual use trial is to enroll a sample based on individuals who present seeking the 
product, and this approximates the likely OTC user population. Actual use trials seek to 
enroll subjects who seek out the product as they are those most likely to use the product 
when available OTC.  In this case, forcing a certain percentage of low-literacy enrollment 
would compromise the representativeness of the sample in a manner that is 
inappropriate. While it is inappropriate to force a specified proportion of low literacy 
subjects in an AUT, it is still important to have a sample of low literacy participants of 
sufficient size to allow for conclusions to be drawn as to performance of study endpoints 
among subjects of low literacy. The total sample size of this study was selected to ensure 
that the absolute size of the subgroup of low literacy participants will be large enough to 
evaluate the endpoints among those of low literacy. If 15% of 950 subjects are classified 
as low literacy by the REALM or REALM-Teen, the cohort of low literacy subjects will be 
approximately 143 subjects, representing a low literary subgroup of sufficient size. As an 
illustration, the 95% confidence interval (exact) around a point estimate of 85% for 143 
subjects is +/-7%. 
6.4 
Interim Follow-Up Telephone Interviews  
During the course of the study, all subjects will be contacted twice via telephone by a 
trained nurse (Interviewer) who will ask a series of questions related to the use of the 
study medication, as well as collect information related to medications and AEs. 

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The answers to these questions will be part of the study database and used to determine 
the performance of the endpoints. There will be a total of 2 phone interviews, one at day 
14 (with an allowable window of ±3 days) and one at day 42±4 days, during which the 
nurses will limit the dialogue with the subjects to the interview script. 
6.5 
End-of-Study/Early Termination Telephone Interview  
The EOS interview will occur at the end of the study (typically this will be in conjunction 
with the 6-week call), or upon early termination from the study. All subjects will be 
contacted via telephone by a trained nurse (Interviewer) who will ask a series of 
questions related to the use of the study medication, as well as collect information related 
to medications and AEs. 
As participation for that subject will then be complete, and therefore the risk of biasing 
future behavior irrelevant, this end-of-study interview will include direct questions about 
how the product was used. The answers to these questions will be part of the study 
database and used to determine the performance of some of the endpoints. 
Typically, the EOS interview will be conducted during the 6-week telephone call 
immediately following the 6-week interim follow-up interview. However, in cases where 
subjects may withdraw earlier for any reason, the EOS interview will be conducted at that 
time. 
6.6 
Pregnancy Testing 
All subjects will be asked directly if they are currently pregnant in the enrollment 
interview. Any subject that reports being pregnant will be disqualified from participation 
in the use phase. Subjects that sign consent will provide a urine sample for the study 
staff member to conduct a urine-based pregnancy test. Subjects with a positive result 
will be informed of the result, asked the selection and purchase question again, and then 
excluded from participating in the use phase. Subjects with a negative result will not be 
provided with the test result, unless they specifically request this information. The 
concern is that a woman who has had recent unprotected sex and seeks EC might 
erroneously interpret a negative pregnancy test as an indication that she does not need 
EC. To minimize this risk, the consent form will contain an explanatory note that 
pregnancy testing cannot detect a pregnancy that may occur as a result of recent 
unprotected sex. At the end of the enrollment interview, subjects who are proceeding 
into the use phase will be given a home pregnancy test (with the instructions to use it) to 
take home and use at the end of the study. Nurse interviewers will inquire about the 
results of the pregnancy test during the EOS interview. An additional call will be placed 
at 7 days ±3 days following the EOS interview to collect that information if the subject 
reported at the EOS interview that they had not yet used the test. This allows for 
shipping time if the subject requires an additional pregnancy test to be sent. In addition, 
at the time a subject withdraws from the study, nurse interviewers will inquire if the 
subject would be willing to take the pregnancy test and report the results. 

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7 
ADVERSE EVENT REPORTING 
7.1 
Adverse Events 
All observed or volunteered AEs regardless of suspected causal relationship to the IP(s) 
will be reported as described in the following sections. This study includes only one 
treatment group. 
While responsibility for collection, recording, and reporting of all AEs will be assumed by 
PEGUS Research, study staff at the study sites will identify any spontaneous reporting of 
AEs to the site staff and facilitate the reporting to the centralized clinical nurse 
interviewers. All site staff and subjects will be provided with a 24-hour toll-free number to 
report any adverse events or other issues. Note that for this section “Investigator” refers 
to the central principal investigator at PEGUS Research who oversees this process.  
For all AEs, the Investigator must pursue and obtain information adequate both to 
determine the outcome of the AE and to assess whether it meets the criteria for 
classification as a serious adverse event (SAE) requiring immediate notification to the 
Sponsor or its designated representative. For all AEs, sufficient information should be 
obtained by the Investigator to determine the causality of the AE. The Investigator is 
required to assess causality. Follow-up by the Investigator may be required until the 
event or its sequelae resolve or stabilize at a level acceptable to the Investigator, and the 
Sponsor concurs with that assessment. 
As part of ongoing safety reviews conducted by the Sponsor, any non-serious AE that is 
determined by the Sponsor to be serious will be reported by the Sponsor as an SAE. To 
assist in the determination of case seriousness further information may be requested 
from the Investigator to provide clarity and understanding of the event in the context of 
the clinical trial. 
7.2 
Reporting Period 
For SAEs, the active reporting period to the Sponsor or its designated representative 
begins from the time that the subject provides informed consent, which is obtained prior 
to the subject’s participation in the use phase of the study, ie, prior to undergoing any 
study-related procedure and/or receiving IP, through and including 28 calendar days after 
the last administration of the IP. SAEs occurring to a subject after the active reporting 
period has ended should be reported to the Sponsor if the Investigator becomes aware of 
them; at a minimum, all SAEs that the Investigator believes have at least a reasonable 
possibility of being related to study drug are to be reported to the Sponsor. 
For non-serious AEs the reporting period begins from the time the subject has taken at 
least 1 dose of study treatment through last subject visit. 
7.3 
Definition of an Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation wherein subjects are 
administered a product or medical device; the event need not necessarily have a causal 
relationship with the treatment or usage. Examples of AEs include but are not limited to: 
• 
Abnormal test findings; 

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• 
Clinically significant symptoms and signs; 
• 
Changes in physical examination findings; 
• 
Hypersensitivity; 
• 
Progression/worsening of underlying disease; 
• 
Drug abuse; 
• 
Drug dependency. 
Additionally, they may include the signs or symptoms resulting from: 
• 
Drug overdose; 
• 
Drug withdrawal; 
• 
Drug misuse; 
• 
Drug interactions; 
• 
Extravasation; 
• 
Exposure during pregnancy; 
• 
Exposure via breastfeeding; 
• 
Medication error; 
• 
Occupational exposure. 
7.4 
Abnormal Test Findings 
The criteria for determining whether an abnormal objective test finding should be reported 
as an AE are as follows: 
• 
Test result is associated with accompanying symptoms, and/or, 
• 
Test result requires additional diagnostic testing or medical/surgical 
intervention, and/or, 
• 
Test result leads to a change in study dosing or discontinuation from the 
study, significant additional concomitant drug treatment, or other 
therapy, and/or, 
• 
Test result is considered to be an AE by the Investigator or Sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does 
not constitute an AE. Any abnormal test result that is determined to be an error does not 
require reporting as an AE. 
7.5 
Serious Adverse Events 
An SAE is any untoward medical occurrence at any dose that: 
• 
Results in death; 
• 
Is life threatening (immediate risk of death); 

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• 
Requires inpatient hospitalization or prolongation of existing hospitalization; 
• 
Results in persistent or significant disability/incapacity (substantial 
disruption of the ability to conduct normal life functions); 
• 
Results in congenital anomaly/birth defect; 
• 
Is a medically important event. 
Medical and scientific judgement is exercised in determining whether an event is an 
important medical event. An important medical event may not be immediately life 
threatening and/or result in death or hospitalization. However, if it is determined that the 
event may jeopardize the subject or may require intervention to prevent one of the other 
AE outcomes, the important medical event should be reported as serious. 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization; or development of drug dependency or drug abuse. 
 Protocol-Specified Serious Adverse Events 
There are no protocol-specified SAEs in this study. All SAEs will be reported by the 
investigator as described in previous sections, and will be handled as SAEs in the safety 
database (see Section on SAE Reporting Requirements). 
7.6 
Hospitalization 
AEs reported from studies associated with hospitalization or prolongations of 
hospitalization are considered serious. Any initial admission (even if less than 24 hours) 
to a healthcare facility meets these criteria. Admission also includes transfer within the 
hospital to an acute/intensive care unit (e.g., from the psychiatric wing to a medical floor, 
medical floor to a coronary care unit, neurological floor to a tuberculosis unit). 
Hospitalization does not include the following: 
• 
Rehabilitation facilities; 
• 
Hospice facilities; 
• 
Respite care (e.g., caregiver relief); 
• 
Skilled nursing facilities; 
• 
Nursing homes; 
• 
Routine emergency room admissions; 
• 
Same day surgeries (as outpatient/same day/ambulatory procedures). 
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical 
AE is not in itself an SAE. Examples include: 
• 
Admission for treatment of a preexisting condition not associated with the 
development of a new AE or with a worsening of the preexisting 
condition (e.g., for work-up of persistent pre-treatment lab abnormality); 
• 
Social admission (e.g., subject has no place to sleep); 

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• 
Administrative admission (e.g., for yearly physical exam); 
• 
Protocol specified admission during a study (e.g., for a procedure 
required by the study protocol); 
• 
Optional admission not associated with a precipitating clinical AE 
(e.g., for elective cosmetic surgery); 
• 
Hospitalization for observation without a medical AE; 
• 
Pre-planned treatments or surgical procedures should be noted in the 
baseline documentation for the entire protocol and/or for the individual 
subject 
Diagnostic and therapeutic non-invasive and invasive procedures, such as surgery, 
should not be reported as AEs. However, the medical condition for which the procedure 
was performed should be reported if it meets the definition of an AE. For example, an 
acute appendicitis that begins during the AE reporting period should be reported as the 
AE and the resulting appendectomy should be recorded as treatment of the AE. 
7.7 
Severity Assessment 
If required on the AE CRFs, the Investigator will use the adjectives MILD, MODERATE, 
or SEVERE to describe the maximum intensity of the AE. For purposes of consistency, 
these intensity grades are defined as follows: 
MILD 
Does not interfere with subject's usual function. 
MODERATE 
Interferes to some extent with subject's usual function. 
SEVERE 
Interferes significantly with subject's usual function. 
Note the distinction between the severity and the seriousness of an AE. A severe event is 
not necessarily an SAE. For example, a headache may be severe (interferes significantly 
with subject's usual function) but would not be classified as serious unless it met one of 
the criteria for SAEs, listed above. 
7.8 
Causality Assessment 
The Investigator’s assessment of causality must be provided for all AEs (serious and non- 
serious). The Investigator must record the causal relationship in the CRF, as appropriate, 
and report such an assessment in accordance with the serious adverse reporting 
requirements if applicable. An Investigator’s causality assessment is the determination of 
whether there exists a reasonable possibility that the investigational product caused or 
contributed to an AE; generally, the facts (evidence) or arguments to suggest a causal 
relationship should be provided. If the Investigator does not know whether or not 
investigational product caused the event, then the event will be handled as “related to 
investigational product” for reporting purposes, as defined by the Sponsor. If the 
Investigator's causality assessment is "unknown but not related to investigational 
product", this should be clearly documented on study records. 
In addition, if the Investigator determines an SAE is associated with study procedures, 
the Investigator must record this causal relationship in the source documents and CRF, 

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as appropriate, and report such an assessment in accordance with the SAE reporting 
requirements, if applicable. 
7.9 
Exposure During Pregnancy 
For IPs and for marketed products, an exposure during pregnancy (EDP) occurs if: 
• 
A female becomes, or is found to be, pregnant either while receiving or being 
exposed (e.g., due to treatment or environmental exposure) or after 
discontinuing or having been directly exposed to the IP; 
• 
A male has been exposed (e.g., due to treatment or environmental exposure) to 
the IP prior to or around the time of conception or is exposed during his partner’s 
pregnancy. 
If a study subject becomes or is found to be pregnant during the study subject’s treatment 
with the IP, the Investigator must submit this information to the Sponsor as an EDP, 
regardless of whether an SAE has occurred. The information submitted should include 
the anticipated date of delivery (see below for information related to termination of 
pregnancy). 
Follow-up is conducted to obtain pregnancy outcome information for all pregnancy 
reports with an unknown outcome. The Investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify the Sponsor of the outcome as a 
follow up to the initial pregnancy report. In the case of a live birth, the structural integrity 
of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
If the outcome of the pregnancy meets the criteria for an SAE (i.e. ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly 
[in a live born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
Investigator should follow the procedures for reporting SAEs. 
Additional information about pregnancy outcomes that are reported as SAEs follows: 
• 
Spontaneous abortion includes miscarriage and missed abortion. 
Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs 
when the Investigator assesses the infant death as related or possibly related to 
exposure to IP. 
Additional information regarding the EDP may be requested by the Investigator. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (e.g., follow-up on 
preterm infants to identify developmental delays). 

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7.10 Withdrawal Due to Adverse Events 
Withdrawal due to AE should be distinguished from withdrawal due to insufficient 
response, according to the definition of AE noted earlier, and recorded on the appropriate 
AE CRF page. 
When a subject withdraws due to an SAE, the SAE must be reported in accordance with 
the reporting requirements defined herein. 
7.11 Eliciting Adverse Event Information 
The Investigator is to report all directly observed AEs and all AEs spontaneously reported 
by the study subject. In addition, each study subject will be questioned about AEs during 
all phone interviews. 
7.12 Reporting Requirements 
Each AE is to be assessed to determine if it meets the criteria for SAEs. If an SAE 
occurs, expedited reporting will follow local and international regulations, as appropriate. 
 Serious Adverse Event Reporting Requirements 
If an SAE occurs, the Sponsor is to be notified within 24 hours of study staff awareness of 
the event. In case of SAE, the investigator must immediately complete the SAE data 
collection form and send it by fax or by email within 24 hours to the Sponsor’s 
Pharmacovigilance Department: 
Fax: +33 1 42 77 03 52 
Email: pharmacovigilance@hra-pharma.com 
 
In particular, if the SAE is fatal or life-threatening, notification to the Sponsor must be 
made immediately, irrespective of the extent of available AE information. This time frame 
also applies to additional new information (follow-up) on previously forwarded SAE 
reports as well as to the initial and follow-up reporting of exposure during pregnancy. 
In the rare event that the Investigator does not become aware of the occurrence of an 
SAE immediately (e.g., if an outpatient study subject initially seeks treatment elsewhere), 
the Investigator is to report the event within 24 hours after learning of it and document the 
time of his/her first awareness of the AE. 
For all SAEs, the Investigator is obligated to pursue and provide information to the 
Sponsor in accordance with the time frames for reporting specified above. In addition, an 
Investigator may be requested by the Sponsor to obtain specific additional follow-up 
information in an expedited fashion. This information collected for SAEs is more detailed 
than that captured on the AE CRF. In general, this will include a description of the AE in 
sufficient detail to allow for a complete medical assessment of the case and independent 
determination of possible causality. Information on other possible causes of the event, 
such as concomitant medications and illnesses must be provided. In the case of a subject 
death, a summary of available autopsy findings must be submitted as soon as possible to 
the Sponsor or its designated representative. 

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 Non-Serious Adverse Event Reporting Requirements 
All AEs will be reported on the AE page(s) of the CRF. It should be noted that the form for 
collection of SAE information is not the same as the AE CRF. Where the same data are 
collected, the forms must be completed in a consistent manner. For example, the same 
AE term should be used on both forms. AEs should be reported using concise medical 
terminology on the CRFs as well as on the form for collection of SAE information. 
 Sponsor Reporting Requirements to Regulatory Authorities 
Adverse event reporting to regulatory authorities, including suspected unexpected serious 
adverse reactions (SUSAR) is the responsibility of the Sponsor PV department and will 
be carried out in accordance with applicable local regulations by the Sponsor. 
8 
DATA MANAGEMENT 
8.1 
EDC System 
Information collected during the subject interviews will be entered directly into an EDC 
application (DATATRAK ONE, DATATRAK International, Inc.). Automatic data checks 
will alert users of discrepancies and inconsistencies, where applicable. In the event of a 
data entry error, users will have the ability to correct information previously entered. Data 
Management will review the information entered as defined in this protocol.  
All users will have a unique login user name and password, and system access 
privileges will be strictly controlled and documented. Whenever data is modified after the 
initial data entry process, a computer-generated audit trail entry will be created. The 
audit trail, user access privilege processes, and electronic signatures collected by the 
system will be compliant with 21 CFR Part 11 requirements.  
If an internet connection is not available, the interview will not be started. If the internet 
connection is lost during the course of an interview, a paper copy of the electronic forms 
will be available to complete the interview. When the Internet connection is restored, 
study staff at the site will enter the data from the paper forms into the EDC system. If this 
were to occur, the completed paper copy of the electronic forms is the source document. 
Otherwise, the electronic record is the source. 
8.2 
Data Management Plan 
A detailed Data Management Plan (DMP) will describe procedures to ensure the proper 
management and quality of study data and additional PEGUS Standard Operating 
Procedures (SOPs) specify the activities performed to ensure the quality, accuracy and 
reliability of the statistical analysis and the final study report.  
8.3 
Conceptual Approach to Self-Selection 
This is not a dedicated self-selection study, however every AUT has some component of 
self-selection, and, in fact, one of the secondary endpoints in this study is the typical 
self-selection metric. 
Conceptually, the self-selection decision can be characterized as a 2x2 table (Table 4 
below) where the subject's decision to select or not select the study product for use is 

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crossed with whether or not it is appropriate for subject to use, based on subject's self-
reported health status and clinical characteristics. 
Table 4 Self-Selection Decision Outcomes 
Subject’s 
Selection Decision 
Appropriate to Use 
YES 
NO 
YES (selectors) 
Cell A 
Correct Decision 
Cell B 
Incorrect Decision 
NO (non-selectors) 
Cell C 
Incorrect Decision 
Cell D 
Correct Decision 
 
The four cells in the self-selection matrix can be characterized as follows.  
Cell A: Subjects who say the study product is right for them to use and based on 
their self-reported medical and demographic information, the study product is 
right for them to use.  
Cell B: Subjects who say the study product is right for them to use and based on 
their self-reported medical and demographic information, the study product is not 
right for them to use.  
Cell C: Subjects who say the study product is not right for them to use and based 
on their self-reported medical and demographic information, the study product is 
right for them to use.  
Cell D: Subjects who say the study product is not right for them to use and based 
on their self-reported medical and demographic information, the study product is 
not right for them to use. 
8.4 
Classification Activities 
In order to evaluate subjects for the relevant endpoints, each subject will be classified on 
two key variables: (1) the selection decision and (2) the appropriateness of use given the 
selection decision, in order to populate the typical 2x2 self-selection table (Table 4 
above). Subjects will be classified on these two variables as described in Sections 8.4.1 
and 8.4.2 below. 
 Selection Decision 
The selection phase of the interview consists of the self-selection question and the 
purchase question, with accompanying neutral follow-up questions. All subjects who go 
on to actually purchase the study product will be categorized as selectors. Even subjects 
who do not eventually complete the purchase of the product will be classified as a 
selector or a non-selector on the basis of the initial selection and purchase questions. 
However, all information recorded during the selection phase of the interview will be 
considered in the classification of subjects as selectors or non-selectors. Subjects who 
offer modifying information in open-ended responses to neutral probing will be re-

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categorized accordingly. Please note that for this study, subjects are offered the 
opportunity to enroll when they present for purchase of EC. That is, these are subjects 
who came to the site having already determined they need EC and expecting to 
purchase EC.  
A subject who initially indicates that they would select and purchase the product, but 
who independently and unprompted changes their purchase decision during the 
selection phase of the interview would be categorized as a non-selector. For the majority 
of subjects, any information offered once the interview proceeds beyond the selection 
phase of the interview will not be considered during selection classification. However, for 
subjects that self-report not being pregnant, sign consent and then receive a positive 
result from the enrollment pregnancy test, the selection questions will be asked again 
and used to classify the subject as a selector or non-selector. Financial and cost-related 
reasons for saying no to the purchase question will not be used as rationale for re-
classifying subjects who would otherwise be selectors.   
The selection decision for each subject will be examined on a case-by-case basis, taking 
into account all the information gathered during the selection phase of the interview. Two 
independent coders will evaluate the available data and indicate whether the subject is a 
selector or a non-selector. Discrepancies will be resolved by a third coder (as described 
in Section 8.4.3). 
 Appropriate to Use 
Non-selectors will be classified on the variable Appropriate for Use as follows: 
Yes: meets the label criteria for use, representing those who could have 
selected appropriately, but did not (Cell C). 
No: does not meet the label requirements for use, and appropriately did not 
select (Cell D). This includes those subjects who otherwise might have met 
the strict criteria for appropriate use according to the DFL, but who give a 
medically appropriate rationale for their non-selection decision. For example, 
if a subject who otherwise meets the labeled criteria for use does not select 
the product and for example cites the desire to use another EC product so 
they can restart hormonal contraception immediately as their reason for not 
selecting, that subject will be re-classified from Cell C to Cell D. A physician 
will review the casebook for each subject who falls into Cell C to determine if 
any subjects meet that criterion. 
Selectors will be classified on the variable Appropriate for Use as follows: 
Yes: either meets the strict label criteria for use (1-Correct Selectors) or 
reported and measured characteristics justify the selection decision (2-
Acceptable Selectors), representing those who chose to use the product who 
made a clinically acceptable decision despite not meeting the strict label 
criteria for use (Cell A). 
No: does not meet strict label criteria and reported and measured 
characteristics do not justify the selection decision (3-Incorrect Selectors), 
representing those who chose to use the product, but should not have (Cell 
B). 
Complete definitions of Correct, Acceptable, and Incorrect Selectors follow: 

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1) Correct Selectors. Subject meets the strict criteria of the Drug Facts label, 
including: 
a) No contraindications (not pregnant or breastfeeding, no known allergy 
to any of the ingredients, no previous use of ella® within the same 
menstrual cycle, no use as regular birth control) 
b) Is a woman of childbearing potential. This would include all women 
who do not report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
c) Has had unprotected sex in the 5 days prior to use of the product  
2) Acceptable Selectors. Subject does not meet the strict criteria of the DFL, 
but selection is classified as appropriate because they are judged 
clinically (see Section 8.4.3) to be an appropriate selector. This group is 
expected to be quite small. 
3) Incorrect Selectors. This group includes selectors who are not correct or 
acceptable, including having any of the following: 
a) A contraindication to the product (are pregnant or breastfeeding, or 
has an allergy to one of the ingredients, previously used ella® within 
the same menstrual cycle, or use as regular birth control) 
b) Is a man 
c) Is a woman without childbearing potential. This would include all 
women who report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
d) Has not had unprotected sex in the 5 days prior to use of the product 
Please note, for the purposes of this study, for all subjects who qualify to purchase the 
product, self-selection will be evaluated at the time of use, rather than time of purchase, 
and each instance of use will be independently evaluated for the self-selection 
endpoints. For example, if a subject purchases two packages of the study product, using 
one immediately and one four weeks later, each of those use instances will be evaluated 
for appropriateness. Because the timing of the most recent episode of unprotected sex is 
one of the elements of appropriate use, behavior surrounding each dosing instance must 
be the basis for self-selection evaluation. 
Subjects who are either pregnant or breastfeeding and who select the product will be 
precluded from purchasing, and will be classified as incorrect selectors. 
 Physician Mitigation 
Subjects occasionally make a decision to select a product for use that according to the 
strict DFL-defined algorithm appears to be an incorrect decision, but, when examined 
clinically, is acceptable. This review and clinical judgement will be done by three 
physicians working independently, evaluating the entire casebook for each Incorrect 
Selector (as defined above in Section 8.4.2) for evidence that the subject made a 
clinically justifiable selection decision. Their assessments are then compared, and any 
discrepancies resolved by a majority rule. 

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Each physician reviewer will review the entire casebook for every subject who falls into 
Cells B or C of the self-selection table. For subjects in Cell B, physicians will make an 
assessment of whether the use instance was acceptable based on clinical judgement of 
the subject’s behavior and her stated reasons for those actions. If yes, each physician’s 
complete rationale for mitigation will be recorded and the subject will be reclassified from 
Cell B to Cell A. For subjects in Cell C, physicians will make an assessment of whether 
the non-selection decision was based on a reasonable medical rationale. If yes, each 
physician’s complete rationale for mitigation will be recorded and the subject will be 
reclassified from Cell C to Cell D. 
 Coding of Open-ended Responses 
The responses to open-ended questions will be coded to make them amenable to 
numeric analysis and display. Coding procedures will follow PEGUS Research SOP 
DAT:008. Once data for at least 50% of subjects has been collected, listings of individual 
responses for each question will be created. The listings will be reviewed to discover the 
underlying conceptual structure suggested by the data, and a coding frame (a list of 
categories, each of which is assigned a one or two-digit number) will be created for each 
question. The coding frames will be reviewed and revised as necessary when 100% of 
the data is collected and cleaned. When the coding frame is finalized, reviewed and 
approved, coding may be performed.  
Coding will be done using data from the final, clean data set. Two coders working 
independently will code each question with a significant number of responses (e.g. >25). 
Their code assignments will then be compared and the Coding Supervisor will resolve 
any discrepancies. Multiple codes (typically no more than seven) may be assigned to 
elements of one response. Once coded, these data will be displayed in standard 
frequency tables. For these tables, the unit of analysis, and thus the denominator, 
changes to become the number of responses rather than the number of subjects. 
9 
DATA ANALYSIS/STATISTICAL METHODS 
A detailed methodology for the statistical analyses of the data collected in this study will 
be documented in a Statistical Analysis Plan (SAP), which will be finalized prior to 
database lock. The SAP may modify the plans outlined in the protocol; however, any 
major modifications to the primary endpoint definition and/or its analysis will also be 
reflected in a protocol amendment. 
This is a naturalistic, observational trial to assess use patterns from the prospective OTC 
population in a simulated OTC setting. The analyses will largely employ descriptive 
statistics including frequencies, percentages and appropriate summary statistics. 
9.1 
Sample Size Determination 
For the purposes of this AUT, sample size has been set for practical and logistical 
reasons at approximately 950 purchasers. Given that subjects are recruited after 
independently seeking EC, most of those who enter the self-selection phase are 
expected to purchase, and most purchasers are expected to actually use the product 
during the study. If approximately 75% of subjects pass the screening criteria, self-select 

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and both qualify and agree to purchase and enter the use phase, it is expected that up to 
1270 subjects will need to be interviewed to yield 950 purchasers. 
Assuming approximately 950 purchasers, if 80% of those purchasers use the product 
within the study period, that would yield a user population of 760. Estimating 
approximately 40% of users will have had recent hormonal contraceptive use would yield 
a recent hormonal contraceptive users population of 305. Allowing for a further 20% loss 
to follow-up yields a user population of approximately 608 and a recent hormonal 
contraceptive user population of 245. 
Because actual use trials are not hypothesis-testing comparative trials, study sample 
size is designed to allow for adequate evaluation of key endpoints across all subjects 
and among several subgroups. As the analysis of actual use trials typically focuses on 
estimating the proportion (and associated 95% confidence intervals) of individual 
endpoints, sample size is most often based on the number of subjects needed to 
constrain the confidence interval (CI) to a limited range. For this study, assuming 85% 
correct response (the confidence interval depends on the actual point estimate), a 
sample of 608 subjects would constrain the CI to ±3.1%. For purposes of illustration, 
Table 5 provides the 2-sided exact 95% confidence interval for various sample sizes 
around a point estimate of 85%. 
Table 5  Two-sided 95% CIs for Various Sample Sizes Around 85% Point Estimate 
 
N=760a 
N=608b 
N=245c 
N=143d 
95% CI around a point estimate of 85% 
±2.7% 
±3.1% 
±5.1% 
±7.0% 
a User population (maximum) 
b User population (allowing for loss-to-follow up) 
c Recent hormonal contraceptive users 
d Low literacy subjects 
 
9.2 
Analysis Populations 
The populations of interests are defined as follows: 
• 
Responder Population:  Subjects who accept the invitation to participate and 
begin the screening process (including those who do not meet screening 
criteria for proceeding to the self-selection phase). 
• 
Self-Selection Population:  Subjects who accept the invitation to participate 
and meet study inclusion criteria, participate in a face-to-face interview at 
the study site and make a self-selection and purchase decision. 
• 
Purchasers:  Subjects who meet study enrollment criteria and purchase the 
study medication. 
• 
User Population:  Subjects who take at least one dose of study medication 
during the study.  
• 
Recent hormonal contraceptive users:  Subjects in the user population who also 
report recent hormonal contraceptive use (i.e., use of a hormonal contraceptive 
within the previous two months). 

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9.3 
Endpoint Analysis 
A summary of the disposition of subjects (including responders, self-selection 
population, purchasers and users) and reasons for exclusion from these populations 
will be provided. Demographic characteristics, medical history and other background 
information will be summarized for the responder, self-selection, purchaser, and user 
populations. 
Frequencies and percentages will be presented for categorical data, mean, standard 
deviation (SD); median, and range will be presented for numerical data. 
Frequencies, percentages and 2-sided 95% CI will be calculated for the primary and 
secondary endpoints using the exact method. For the primary endpoints, it will be 
concluded that the established target threshold is reached if the lower limit of the CI of 
the point estimate is equal to or exceeds the value of the pre-determined threshold.  
Several of the endpoints are based on dosing instance, rather than by subject, as 
subjects have the potential to take more than one dose over the course of the study.  
Correctness of selection or behavior can only be evaluated at the time of use, rather 
than at the time of purchase.  However, for each of those endpoints a secondary 
analysis by subject will also be presented. 
Endpoints and demographics will be presented for subgroups of interest, with subjects 
dichotomized on the corresponding variables, which include (but are not necessarily 
limited to) literacy, gender, age (adolescent vs. adult women), and history of HBC use. 
A more detailed description of planned data analysis procedures will be found in the 
SAP which will be approved and signed before the database is locked. 
 Primary Endpoint Analysis 
Frequencies, percentages and two-sided exact 95% confidence intervals will be 
calculated for the three primary endpoints for the entire study population and for selected 
subgroups. 
9.3.1.1 A:  Actual Use:  Proportion of dosing instances among user population taken 
within 120 hours (5 days) of most recent episode of unprotected sex. 
The first primary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP and the numerator includes all dosing instances of the IP which were 
taken within 120 hours (5 days) of the subject’s most recent episode of unprotected sex. 
9.3.1.2 B:  Actual Use:  Proportion of dosing instances among user population in which 
no more than one tablet was taken. 
The second primary endpoint is the proportion in which the denominator is all discrete 
dosing instances of the IP and the numerator includes all dosing instances where no 
more than one tablet was taken. 

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9.3.1.3 C:  Self-Selection:  Proportion of female selectors who are not pregnant at the 
time of selection decision. 
The third primary endpoint is the proportion in which the denominator includes all 
females who selected to use the product (regardless of whether they purchased/used) 
and the numerator includes all female selectors who were not pregnant at the time of the 
selection decision. In the case of subjects that report not being pregnant, sign consent 
and then receive a positive result on the pregnancy test, the second selection decision 
will be used for analysis of this endpoint. 
 Target Thresholds 
The threshold for the three primary endpoints is 90%. The objective will be considered 
met for these endpoints if the lower bound of the 2-sided 95% CI for each endpoint 
meets or exceeds the established threshold. 
• 
A:  Actual use: Proportion of dosing instances among user population taken 
within 120 hours (5 days) of most recent episode of unprotected sex. 
The Sponsor proposes to test this message as a primary endpoint because it 
communicates directions for effective use of ella®, and the limited time-window for its 
effective use. Use of ella® after 5 days diminishes or abolishes the product’s efficacy, 
although it is not expected to introduce any drug-related risks. Despite the fact that this 
label language is almost identical to the label language tested, approved, and in-market 
for Plan B One-Step (PBOS) (which is “Take as soon as possible and no later than 3 
days (72 hours) after unprotected sex”), the Sponsor will test this as a primary endpoint. 
Testing it as a primary endpoint would test whether the longer time window (5 vs 3 days) 
during which consumers may benefit from ella® use is well-followed. This would also 
allow us to confirm that consumers do not take ella® later after unprotected intercourse 
than recommended in the product label. 
A performance threshold of 90% is proposed because while taking the product within the 
5-day window is very important to maximize effectiveness, taking it outside of the 5 days 
window is not expected to introduce any serious drug-related risks. 
• 
B:  Actual Use:  Proportion of dosing instances among user population in which 
no more than one tablet was taken. 
The Sponsor proposes to test this message as a primary endpoint in the context of 
FDA’s recommendation to demonstrate in an AUT whether consumers misuse ella® and 
one of the potential misuse scenarios would be the intake of more than the 
recommended dose, which would be assessed through this endpoint.  
A threshold of 90% was designated despite the fact that dose-finding studies using up to 
200 mg of UPA (more than 6 times the intended 30 mg dose) demonstrated no safety 
concerns (HRA2914-503). Accordingly, it is likely that taking more than the 
recommended dose is likely to impose little or no additional risk in women. 

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• 
C:  Self-Selection:  Proportion of female selectors who are not pregnant at the 
time of selection decision.  
The Sponsor proposes to test this message as a primary endpoint as it would allow the 
study to confirm that consumers do not select ella® if they know they are already 
pregnant. 
Of important note, the caution against use if already pregnant is on the approved and 
marketed PBOS DFL that uses the exact same language as that proposed on the ella® 
DFL (“Do not use if you are already pregnant (because it will not work)”. The ella® LCS 
demonstrated that consumers understand this warning extremely well. Moreover, data 
suggest use of ella® in pregnancy is safe. For ella®, the analysis of the global pregnancy 
safety database conducted in the context of the Ellipse II study has been specifically 
intended to assess the occurrence rates of outcomes of pregnancies exposed to ella® 
due either to failure of the EC or inadvertent exposure during pregnancy, including fetal 
and neonatal outcomes and maternal pregnancy complications. Data from the collected 
UPA-exposed pregnancies did not reveal a negative signal on the course of the 
pregnancy, its outcome, or the growth and development of the embryo and the fetus. 
Despite the fact that the available safety data are reassuring were a pregnant woman to 
take ella®, this has been designated as a primary endpoint in this AUT with a 90% 
threshold. 
 Secondary Endpoint Analysis 
9.3.3.1 D:  Self-Selection:  Proportion of female selectors who are not breastfeeding at 
the time of selection decision. 
The first secondary endpoint is the proportion in which the denominator includes all 
females who selected to use the product (regardless of whether they purchased/used) 
and the numerator includes all female selectors who were not breastfeeding at the time 
of the selection decision. 
9.3.3.2 E:  Self-Selection:  Proportion of self-selection population who make a correct 
selection decision regarding use of the product. 
This endpoint is the proportion of those subjects making the self-selection decision who 
make a correct decision about whether the product is right for them to use, as outlined 
below. 
9.3.3.2.1 Populating the Self-Selection Table 
Each subject will be classified on two key variables: (1) the selection decision and (2) the 
appropriateness of use given the selection decision, in order to populate the typical 2x2 
self-selection table. 
Selection Decision:  The selection phase of the interview consists of the self-selection 
and purchase questions, with accompanying neutral follow-up questions. All subjects 
who go on to actually purchase the study product will be categorized as selectors. Even 

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subjects who do not eventually complete the purchase of the product will be classified as 
a selector or a non-selector primarily on the basis of the initial self-selection and 
purchase questions, or in the case of a positive enrollment pregnancy result, the second 
self-selection and purchase question. However, all information recorded during the 
selection phase of the interview will be considered in the classification of subjects as 
selectors or non-selectors. Subjects who offer modifying information in open-ended 
responses to neutral probing will be re-categorized accordingly. 
 
Appropriate to Use:   
Non-selectors will be classified on the variable Appropriate for Use as follows: 
Yes: meets the label criteria for use, representing those who could have 
selected appropriately, but did not (Cell C). 
No: does not meet the label requirements for use, and appropriately did not 
select (Cell D). This includes those subjects who otherwise might have met 
the strict criteria for appropriate use according to the DFL, but who give a 
medically appropriate rationale for their non-selection decision. For example, 
if a subject who otherwise meets the labeled criteria for use does not select 
the product and cites the fact that they are taking a medicine for Human 
Immunodeficiency Virus (HIV) as their reason for not selecting (which 
otherwise does not disqualify a subject from using, but rather suggests that 
they talk to a doctor), that subject will be re-classified from Cell C to Cell D. A 
physician will review the casebook for each subject who falls into Cell C to 
determine if any subjects meet that criterion. 
Selectors will be classified on the variable Appropriate for Use as follows: 
Yes: either meets the strict label criteria for use (1-Correct Selectors) or 
reported and measured characteristics justify the selection decision (2-
Acceptable Selectors), representing those who chose to use the product who 
made a clinically acceptable decision despite not meeting the strict label 
criteria for use (Cell A). 
No: does not meet strict label criteria and reported and measured 
characteristics do not justify the selection decision (3-Incorrect Selectors), 
representing those who chose to use the product, but should not have (Cell 
B). 
Complete definitions of Correct, Acceptable, and Incorrect Selectors follow: 
4) Correct Selectors. Subject meets the strict criteria of the Drug Facts label, 
including: 
a) No contraindications (not pregnant or breastfeeding, no known allergy 
to any of the ingredients, no previous use of ella® within the same 
menstrual cycle, no use as regular birth control) 
b) Is a woman of childbearing potential. This would include all women 
who do not report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
c) Has had unprotected sex in the 5 days prior to use of the product  

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5) Acceptable Selectors. Subject does not meet the strict criteria of the Drug 
Facts label, but selection is classified as appropriate because they are 
judged clinically (see Section 8.4.3) to be an appropriate selector. This 
group is expected to be quite small. 
6) Incorrect Selectors. This group includes selectors who are not correct or 
acceptable, including having any of the following: 
a) A contraindication to the product (are pregnant or breastfeeding, has 
an allergy to one of the ingredients, previously used ella® within the 
same menstrual cycle, or use as regular birth control) 
b) Is a man 
c) Is a woman without childbearing potential. This would include all 
women who report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
d) Has not had unprotected sex in the 5 days prior to use of the product 
 
9.3.3.2.2 Analyzing the Self-Selection Table 
Cell A represents a correct decision, namely consumers for whom the study product is 
right to use who choose to use it, and therefore presents very little potential adverse 
clinical consequences.  
Cell C, while not technically correct, is a decision that accrues no health risk, but rather 
is a missed opportunity to use the drug. Thus, these subjects are considered neither 
correct nor incorrect and are usually left out of the primary self-selection analysis. 
The most critical self-selection decision is made by subjects who, based on their health 
status, should not use the study drug (cells B and D). Unlike an incorrect decision by 
consumers for whom this product is appropriate (cell C), an incorrect decision (cell B) by 
these consumers has potential efficacy or safety implications. 
Because it is expected that very few subjects will be inappropriate for use, this endpoint 
will be measured by the following proportion, taken from the self-selection table [(cell A + 
cell D)/(cell A + cell B + cell D)]. Again, note that this does not take into account cell C, 
as those subjects could have chosen to use the product, but did not (for whatever 
reason). 
Other proportions will also be presented, including the total correct selectors as 
described by the equation [(cell A + cell D) / (cell A + cell B + cell C + cell D)] and the 
typical self-selection metric, namely the proportion described by the equation [cell D/(cell 
B + cell D)]. This proportion represents a correct non-selection decision. In other words, 
this is the proportion of those who should not select the product who correctly do not 
select it. 

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9.3.3.3 F:  Actual Use:  Proportion of dosing instances among user population in which 
HBC is not taken for 5 days after taking ella® 
This secondary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP and the numerator includes all dosing instances in which there is no 
reported use of HBC for at least 5 days. 
9.3.3.4 G:  Actual Use:  Proportion of dosing instances among user population 
associated with use of hormonal contraceptives in the same cycle after taking 
ella® in which subject reports using a condom (or other barrier method) every 
time they have sex until their next menstrual period. 
This secondary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP among those who start or restart hormonal contraception in the same 
menstrual cycle and the numerator includes dosing instances where the subject reports 
using condoms every time they have sex during the remainder of that menstrual period. 
9.3.3.5 H:  Actual Use:  Proportion of user population who do not use the study product 
more than once in the same menstrual cycle. 
This secondary endpoint is the proportion in which the denominator includes all subjects 
who take at least one dose of the product (user population) and the numerator includes 
all subjects who do not use more than one dose(s) of the study product within the same 
menstrual cycle after taking the initial dose of ella®. 
9.3.3.6 I:  Self-Selection/Actual Use:  Proportion of self-selection population taking one 
of the “ask a doctor or pharmacist before use” products who do not select, who 
select but do not use or who report contacting a healthcare provider or 
pharmacist. 
This secondary endpoint is the proportion defined by the denominator including all 
subjects who participate in the self-selection interview who report taking one of the “ask 
a doctor or pharmacists before use” compounds (including barbiturates, carbamazepine, 
felbamate, oxcarbazepine, phenytoin, topiramate, rifampin, griseofulvin, a prescription 
drug to treat HIV/AIDS, bosentan, or a supplement containing St. John’s Wort) and the 
numerator is all such subjects who either do not select or use or who report talking with 
a doctor or pharmacist about it use during the course of the study.  
 Other Measures Analysis 
The other measures are all simple proportions where the user population represents the 
denominator. 
J. Proportion of user population who use a HBC method sometime during the past 
two menstrual cycles. 
K. Proportion of user population who used any EC on more than one occasion 
within the study period. 

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L. Proportion of user population who report becoming pregnant within the study 
period. 
9.4 
Safety Analysis 
Adverse event (AE) analyses will include all events which initially occurred, or worsened 
following treatment. Adverse events will be summarized by the Medical Dictionary for 
Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT) 
and classified according to their severity (mild, moderate, or severe) and relationship 
(related or not related) to study product. For the summary by severity, subjects who have 
multiple occurrences of the same AE will be classified according to the worst reported 
severity of the AE. Similarly, for the summary by relationship to the study product, the 
AE will be classified according to the worst relationship. 
9.5 
Interim Analysis 
There will be no interim analysis for this study 
9.6 
Missing Data 
All missing data will be considered missing and no statistical procedures will be 
employed to estimate or impute missing data. 
9.7 
Open-ended Data 
Verbatim responses will be coded as described in Section 8.4.4 above, with coded 
responses presented within individual question tables. For all verbatim responses 
(including those which were coded), listings will be generated and presented. 
10 DATA HANDLING AND RECORD KEEPING 
10.1 Data Collection Instruments / Electronic Data Record 
As used in this protocol, the term CRF should be understood to refer to a paper data 
record, an electronic data record or both, depending on the data collection method used 
in this study. 
A CRF is required and should be completed for each included subject. The completed 
original CRFs are the sole property of the Sponsor and should not be made available in 
any form to third parties, except for authorized representatives of the Sponsor or 
appropriate regulatory authorities, without written permission from the Sponsor. 
Each investigator has ultimate responsibility for the collection and reporting of all the 
clinical, safety, and laboratory data entered on the CRFs and any other data collection 
forms (source documents) that pertain to his or her phase of the study (enrollment 
interview and purchase for site investigators, follow up interviews and AE reports for the 
central investigator). Each investigator is responsible for ensuring that data collected are 
accurate, authentic/original, attributable, complete, consistent, legible, timely 
(contemporaneous), enduring, and available when required. The CRFs must be signed 
by the investigator or by an authorized staff member to attest that the data contained on 
the CRFs are true. Any corrections to entries made in the CRFs or source documents 

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must be dated, initialed, and explained (if necessary) and should not obscure the original 
entry.  
In most cases, the CRF, or part of the CRF, will also serve as source documents. In 
these cases, a document should be available at the investigator’s site as well as at the 
Sponsor and clearly identify those data that will be recorded in the CRF, and for which 
the CRF will stand as the source document. 
Data for this study will be entered directly into a validated EDC system. This system will 
provide a complete audit trail, which includes information about the initial data entry and 
all changes and deletions. When the data collection form is saved, data edits will check 
entries in each field and provide immediate notification to the interviewer of data that is 
unacceptable (a different value must be entered) or questionable (the data field must be 
checked and if left intact, an explanation must be given). Using this system, the 
interviewer will be able to correct entries or make clarifications while the subject is still 
being interviewed. 
All users will have a unique login user name and password, and system access 
privileges will be strictly controlled and documented. The audit trail, user access privilege 
processes, and electronic signatures collected by the system will be compliant with 21 
CFR Part 11 requirements. 
If the internet connection fails during the course of an interview, data collection will be 
completed on a paper copy of the electronic forms. When the internet connection is 
restored, study staff at the site will enter the data from the paper forms into the EDC 
system. If this were to occur, the completed paper copy of the electronic forms is the 
source document. Otherwise, the electronic record is the source. 
10.2 Study Documentation 
PEGUS Research will maintain accurate and complete records of the study. Study files 
and critical documents will be maintained at PEGUS Research throughout the study 
period, and will be retained or transferred to the Sponsor at its direction. 
10.3 Confidentiality of Study Documents and Electronic Records 
PEGUS Research holds all study-related documents and communications in the strictest 
confidence. PEGUS Research will ensure that the subject’s anonymity is maintained. On 
documents submitted to the Sponsor, subjects will not be identified by name or other 
personally identifiable information, but by numerical identification code. 
11 QUALITY CONTROL AND QUALITY ASSURANCE 
The procedures described herein pertaining to the conduct, evaluation and 
documentation of this study are designed to ensure that the Sponsor and study 
personnel abide by Good Clinical Practice (GCP) guidelines. The study will also be 
carried out in keeping with applicable local law(s) and regulation(s).  
SOPs from PEGUS Research will be followed to ensure quality. PEGUS staff will train 
and approve prospective interviewers prior to their work on the study. PEGUS Research 

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is responsible for selecting sites and training study personnel. Training will consist of an 
overview of the purposes and design of the study as well as detailed instructions on the 
methods, including subject recruitment, proper administration of the questionnaire, use 
of the EDC application and guidelines for correctly capturing and entering responses. A 
study-specific interviewer-training guide will be developed to serve as the basis for 
training. All training will be documented. 
Regulatory authorities, the Institutional Review Board / Independent Ethics Committee, 
and / or the sponsor’s or CRO’s clinical quality assurance group may request access to 
all source documents, CRFs, and other study documentation for on-site audit or 
inspection. Direct access to these documents must be guaranteed by the investigator, 
who must provide support at all times for these activities. 
12 ETHICS 
The study will be carried out in keeping with applicable local law(s) and regulation(s).  
12.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the study 
protocol, protocol amendments, informed consent documents, and other relevant 
documents, e.g., recruitment posters, if applicable, from the IRB/IEC. All 
correspondence with the IRB/IEC will be retained in the investigator file. Copies of 
IRB/IEC approvals will be forwarded to the Sponsor. 
The only circumstance in which an amendment may be initiated prior to IRB/IEC 
approval is where the change is necessary to eliminate apparent immediate hazards to 
the subjects. In that event, the investigator must notify the IRB/IEC and the Sponsor in 
writing immediately after the implementation. 
12.2 Ethical Conduct of the Study 
The study will be conducted in accordance with legal and regulatory requirements, as 
well as the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations 
of Medical Sciences 2002), Guidelines for GCP (ICH 1996), and the Declaration of 
Helsinki (World Medical Association 2013).  
In addition, the study will be conducted in accordance with the protocol, the International 
Conference on Harmonization (ICH) guideline on GCP, and applicable local regulatory 
requirements and laws. 
PEGUS Research will oversee the process for the approval of all Investigators, trial 
protocol, informed consent forms and other relevant trial documents. All correspondence 
with the IRB will be retained in the trial files for each site. All records identifying subjects 
will be kept confidential and, to the extent permitted by the applicable laws and/or 
regulations, will not be made publicly available. Subject names will be collected for 
compensation and follow-up purposes only and will not be linked to any study data. This 
information will not be supplied to the Sponsor or any other entity. No personally 

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identifiable information (PII) will be captured in the study database. In accordance with 
the Federal Privacy Standard, a Notice of Information Practices, which describes how 
subjects’ health information will be used and disclosed and how they can obtain access 
to this information, will be made available, if applicable. 
12.3 Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject 
names or other identifiable data in any reports, publications, or other disclosures, except 
where required by law.  Explicit permission to gather sensitive data will be sought and 
documented prior to any data collection.  No PHI will be collected for subjects that 
screen fail, do not qualify for the use phase of the study, or choose not to sign consent.  
Any data collected after explicit permission is granted will be retained as anonymous 
study data for use by the sponsor. 
The informed consent documents must be in compliance with ICH GCP, local regulatory 
requirements, and legal requirements, including applicable privacy laws. 
The informed consent documents used during the informed consent process must be 
reviewed by the Sponsor, approved by the IRB/IEC before use, and available for 
inspection.  
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject before dispensing of study medication. The investigator will 
retain the original of each subject's signed consent document. 
Adolescents recruited in this study, as some may not have a high degree of parental 
involvement and since requirement of parental consent might introduce risk in some 
circumstances, are NOT children for the purposes of this study. This is allowed for in 45 
CFR 46.408 (c) “…if the IRB determines that a research protocol is designed for 
conditions or for a subject population for which parental or guardian permission is not a 
reasonable requirement to protect the subjects (for example, neglected or abused 
children), it may waive the consent requirements… provided an appropriate mechanism 
for protecting the children who will participate as subjects in the research is substituted, 
and provided further that the waiver is not inconsistent with federal, state, or local law. 
The choice of an appropriate mechanism would depend upon the nature and purpose of 
the activities described in the protocol, the risk and anticipated benefit to the research 
subjects, and their age, maturity, status, and condition.”  Since adolescents are 
presenting to the research sites seeking emergency contraceptives on their own accord, 
they meet the criteria for a mature minor in most states. Moreover, in most cases, 
adolescents seeking emergency contraception would not need parental consent for 
treatment and reproductive services in most states, and may not meet the definition of 
“children” in § 50.3(o) and thus would not be subject to the requirements of 21 CFR 50 
subpart D. The definition provided is “Children means persons who have not attained the 
legal age for consent to treatments or procedures involved in clinical investigations, 
under the applicable law of the jurisdiction in which the clinical investigation will be 
conducted.” However, depending on the age of the adolescent enrolling in the study, 
some state laws and regulations may preclude the adolescent from receiving 
contraceptive services without parent consent (i.e., under age 12 in many states). Where 

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state and local laws require, parental consent and adolescent subject assent will be 
documented. 
All records identifying subjects will be kept confidential, and to the extent permitted by 
the applicable laws and/or regulations, will not be made publicly available. Subject 
names will be collected for compensation and follow-up phone calls only. No personal 
identifiable information (PII) will be stored in the study database. This information will not 
be supplied to the Sponsor or any other entity. In accordance with the Federal Privacy 
Standard, a Notice of Information Practices, which describes how subjects’ health 
information will be used and disclosed and how they can obtain access to this 
information, will be made available, if applicable. 
Subjects’ implicit consent will be obtained prior to collecting any personally-identifiable 
contact information. Explicit verbal consent to gather sensitive data will be requested 
and documented prior to collecting any health or other sensitive information. 
Subject names, contact information, and other identifiable data will be maintained 
entirely separate from the study database. All parties will ensure protection of subject 
personal data and will not include subject names on any data forms, reports, 
publications, or in any other disclosures, except where required by laws. Personally-
identifiable data will be replaced by a numerical code consisting of a numbering system 
generated by the EDC system in order to de-identify the study subject. In case of data 
transfer, PEGUS will maintain high standards of confidentiality and protection of subject 
personal data. 
12.4 Liability and Insurance 
The Sponsor has subscribed to an insurance policy covering, in its terms and provisions, 
its legal liability for injuries caused to participating persons and arising out of this 
research performed strictly in accordance with the scientific protocol as well as with 
applicable law and professional standards. 
12.5 Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP 
In the event of any prohibition or restriction imposed (i.e., clinical hold) by an applicable 
competent authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the IP, the 
Sponsor should be informed immediately.  
In addition, the investigator will inform the Sponsor immediately of any urgent safety 
measures taken by the investigator to protect the study subjects against any immediate 
hazard, and of any serious breaches of this protocol or of ICH GCP that the investigator 
becomes aware of. 
12.6 Mandatory Reporting 
There will not be questions in the interview addressing personal sexual experience and it 
is not expected that subjects will spontaneously disclose information that would trigger 
mandatory reporting requirements. However, interviewers will be trained in the 
mandatory reporting conditions in each state where the interviews are conducted and to 

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identify such conditions if they are reported by subjects. Subjects will be informed in the 
introduction to the study that confidentiality will be strictly guarded, except for 
circumstances requiring reporting to authorities. 
13 SPONSOR DISCONTINUATION CRITERIA 
Premature termination of this study may occur because of a regulatory authority 
decision, change in opinion of the IRB/IEC, drug safety problems, or at the discretion of 
the Sponsor. In addition, the Sponsor retains the right to discontinue development of 
ella® at any time. 
If a study is prematurely terminated or discontinued, the Sponsor will promptly notify the 
investigator. After notification, the investigator must contact all participating subjects and 
the participating pharmacy and health center study sites. As directed by the Sponsor, all 
study materials must be collected and all CRFs completed to the greatest extent 
possible. 
14 PUBLICATION OF STUDY RESULTS 
14.1 Communication of Results by the Sponsor 
The Sponsor fulfills its commitment to publicly disclose clinical trial results through 
posting the results of studies on www.clinicaltrials.gov (ClinicalTrials.gov) and/or the 
European Clinical Trials Database (EudraCT), and other public registries in accordance 
with applicable local laws/regulations. 
15 EMERGENCY CONTACTS 
In emergency situations, the investigator should contact PEGUS Research Inc. by 
telephone on the number listed on the title page of the protocol. 
16 STUDY DURATION AND DATES 
The duration of this study is expected to be around 6 months (from first subject enrolled 
in the study until last subject last visit), with subject recruitment proposed to start mid Q2 
2017 and end in Q4 2017. The actual overall study duration or subject recruitment period 
may vary. 
 

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17 REFERENCES 
1. Murphy, Peggy W.; Davis, Terry C.; Long, Sandra W.; Jackson, Robert H.; Decker, 
Barbara C. Rapid Estimate of Adult Literacy in Medicine (REALM): a quick reading test 
for patients. Journal of Reading 1993 Oct; 37(2):124-30. 
2. Davis TC, Wolf MS, Arnold CL, Byrd RS, Long SW, Springer T, Kennen E, Bocchini 
JA. Development and validation of the Rapid Estimate of Adolescent Literacy in 
Medicine (REALM-Teen): a tool to screen adolescents for below-grade reading in health 
care settings. Pediatrics. 2006 Dec 1;118(6):e1707-14. 
3. Brache et al. A prospective randomised pharmacodynamic study of quick-starting a 
desogestrel progestin-only pill following ulipristal acetate for emergency contraception. 
Human Reproduction 2015; 30 (12) 2785-93. 
4. Zapata LB, Steenland M, Brahami D, Marchbanks PA, Curtis K. Effect of missed 
hormonal contraceptives on contraceptive effectiveness: a systematic review. 
Contraception 2013;87 (5): 685-700. 
 
 

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18 APPENDICES 
18.1 Mock Package and Drug Facts Label 
 
 
 
 

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18.2 Consumer Information Leaflet 
 
 
 
 
 

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