Evaluation of the Effectiveness, Safety and Tolerability of LevoCept (Levonorgestrel-Releasing Intrauterine System) for Long-Acting Reversible Contraception
Phase: PHASE2
Conditions: Contraception
Sponsor: Sebela Women's Health Inc.

NCT02882191  
STUDY PROTOCOL 
Evaluation of the Effectiveness, Safety and Tolerability of LevoCept (Levonorgestrel-
Releasing Intrauterine System) for Long-Acting Reversible Contraception  
DOCUMENT DATE: 18 Oct 2017 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 2 of 47 
Investigator’s Agreement 
 
I have received a copy of the protocol number CMDOC-0022, Evaluation of the 
Effectiveness, Safety and Tolerability of LevoCept (Levonorgestrel -Releasing 
Intrauterine System) for Long-Acting Reversible Contraception, Version 3.0, dated  
30 March 2017 from ContraMed. I/we agree to the conditions as set out in this protocol 
and fully accept that any change requires prior approval from ContraMed. Additionally, 
I/we agree to carry out all terms of this protocol in accordance with ICH Guidelines; all 
applicable US Regulations (21 CFR parts 50, 54, 56 and 312) and Good Clinical 
Practice Guidelines, as applicable. Finally, I/we will ensure that the investigational 
product will be used only as described in this protocol. 
 
The information contained in this protocol is provided to me in confidence, for review 
only by myself, the Independent Ethics Committee / Investigational Review Board 
authorized to review and approve the study at this study site, the designated research 
staff participating in this clinical study, and applicable regulatory agencies. 
 
I/we understand that the information/technology contained in this protocol is proprietary 
and may not be disclosed to any other party, in any form, without prior authorization from 
ContraMed, except to the extent necessary to obtain informed consent from potential 
study participants. 
 
 
 
 
 
 
Investigator’s Name (print) 
 
 
Investigator’s Signature 
 
Date(DD/MMM/YYYY) 
 
 
 
 
 
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 3 of 47 
TABLE OF CONTENTS 
 
INVESTIGATOR’S AGREEMENT ............................................................................................................ 2 
TABLE OF CONTENTS.............................................................................................................................. 3 
REVISION HISTORY ................................................................................................................................. 6 
INVESTIGATIONAL PLAN SUMMARY ................................................................................................. 7 
SUBJECTS NOT USING ANY HORMONAL BIRTH CONTROL METHOD (INCLUDES COPPER 
IUDS).......................................................................................................................................................... 11 
ABBREVIATIONS AND DEFINITIONS OF TERMS ......................................................................... 13 
1. INTRODUCTION ............................................................................................................................. 15 
2. STUDY DURATION ........................................................................................................................ 15 
3. INVESTIGATIONAL PRODUCT DESCRIPTION ...................................................................... 16 
4. STUDY TREATMENTS .................................................................................................................. 17 
4.1 
LEVOCEPT INSERTION TIMING ............................................................................................ 17 
4.1.1 
SUBJECTS USING ANY HORMONAL BIRTH CONTROL METHOD ............................ 17 
4.1.2  
SUBJECTS NOT USING ANY HORMONAL BIRTH CONTROL METHOD (INCLUDES 
COPPER IUDS) ........................................................................................................................................ 18 
4.2 
LEVOCEPT INTRAUTERINE CONTRACEPTIVE (DOSAGE AND FORMULATION) .. 18 
4.3 
LEVOCEPT SUPPLY AND ADMINISTRATION .................................................................... 18 
4.4 
LEVOCEPT STORAGE AND ACCOUNTABILITY ................................................................. 18 
4.5 
LEVOCEPT DOSAGE MODIFICATION ................................................................................... 18 
4.6 
CONCOMITANT THERAPY ...................................................................................................... 18 
4.7 
LEVOCEPT RETENTION COMPLIANCE ............................................................................... 19 
5. OBJECTIVES ..................................................................................................................................... 19 
5.1 
PRIMARY OUTCOME MEASURE ............................................................................................ 19 
5.2 
SAFETY AND OTHER OUTCOME MEASURES .................................................................... 19 
6. BENEFITS AND RISKS ................................................................................................................... 19 
6.1 
POTENTIAL BENEFITS ............................................................................................................. 19 
6.2 
POTENTIAL RISKS / ADVERSE REACTIONS...................................................................... 19 
6.3 
MINIMIZATION OF ANTICIPATED RISKS .......................................................................... 20 
6.4 
SAFETY REVIEW ........................................................................................................................ 21 
7. SELECTION AND TRAINING OF CLINICAL SITES AND INVESTIGATORS ..................... 21 
7.1 
LABORATORIES ......................................................................................................................... 22 
8. STUDY POPULATION .................................................................................................................... 22 
8.1 
INCLUSION ................................................................................................................................... 22 
8.2 
EXCLUSION .................................................................................................................................. 23 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 4 of 47 
9. INFORMED CONSENT ................................................................................................................... 24 
10. 
ENROLLMENT ............................................................................................................................. 25 
11. 
STUDY SCHEDULE OF ASSESSMENTS ................................................................................. 26 
TABLE 1. 
STUDY SCHEDULE OF ASSESSMENTS ..................................................................... 26 
12. 
STUDY PROCEDURES ............................................................................................................... 27 
12.1 
VISIT 1: SCREENING .............................................................................................................. 27 
12.2 
VISIT 2: LEVOCEPT PLACEMENT (DAY 1) ..................................................................... 28 
12.3 
VISITS 3-6 FOLLOW-UP (WEEK 6±1W,13±2W, 26±2W AND 52±2W/) .............. 29 
12.3.1 EXIT VISIT (VISIT 2 – VISIT 6/WEEK 52) ...................................................................... 29 
12.3.2 SUBJECTS EXITING THE STUDY DUE TO IUD EXPULSION: ...................................... 30 
12.3.3 MONTHLY CONTACT (UP TO 52 WEEKS ± 1 W) ......................................................... 30 
12.4 
LONG-TERM FOLLOW-UP, POST 52-WEEKS VISIT (EVERY 6 MONTHS: MONTHS 
18-30 (±4WKS) AND 3 YRS (-3WKS/+4WKS) ............................................................................. 31 
12.4.1 END OF EACH 28-DAY CYCLE CONTACT (POST 52 WEEKS + 1 W) ....................... 31 
12.4.2 EXIT VISIT (POST VISIT 6/WEEK 52 – YEAR 3) .......................................................... 31 
12.4.2 SUBJECTS EXITING THE STUDY DUE TO IUD EXPULSION: ...................................... 32 
12.5 
EARLY DISCONTINUATION VISIT .................................................................................... 32 
12.6 
UNSCHEDULED VISITS ......................................................................................................... 32 
12.7 
EMERGENCY CONTRACEPTION ........................................................................................ 33 
12.8 
LOST TO FOLLOW-UP .......................................................................................................... 33 
13. 
DIARIES ......................................................................................................................................... 33 
14. 
CONCOMITANT MEDICATIONS ............................................................................................. 33 
15. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ..................................................... 33 
15.1 
DEFINITION OF A SERIOUS ADVERSE EVENT .............................................................. 34 
15.2 
DEFINITION OF AN ADVERSE EVENT ............................................................................. 34 
15.3 
CAUSALITY: SERIOUS ADVERSE EVENT AND ADVERSE EVENT RELATIONSHIP 
TO STUDY TREATMENT ...................................................................................................................... 35 
15.3.1 CLARIFICATION OF ADVERSE EVENTS RELATED TO STUDY PROCEDURES ..... 35 
15.4 
SERIOUS ADVERSE EVENT AND ADVERSE EVENT SEVERITY ................................ 35 
15.5 
ADVERSE EVENT OUTCOME .............................................................................................. 36 
15.6 
PROMPT REPORTING OF SAES TO SPONSOR .............................................................. 36 
15.7 
CLINICAL LABORATORY ABNORMALITIES AND OTHER ABNORMAL 
ASSESSMENTS AS ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ............................. 37 
15.8 
DOCUMENTING ADVERSE EVENTS .................................................................................. 37 
15.9 
FOLLOW-UP OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ................. 38 
15.10 
CLARIFICATION IN REPORTING OF DEATHS ............................................................... 38 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 5 of 47 
15.11 
POST-STUDY TREATMENT REPORTING REQUIREMENTS ...................................... 38 
15.12 
STUDY DEVICE MALFUNCTION ......................................................................................... 38 
16. 
PROTOCOL VIOLATIONS AND DEVIATIONS ..................................................................... 38 
17. 
SUBJECT CONFIDENTIALITY ................................................................................................. 39 
18. 
PREGNANCY DETERMINATION AND FOLLOW UP ......................................................... 39 
19. 
DATA MONITORING AND QUALITY CONTROL ................................................................ 40 
19.1 
MONITORING OF CLINICAL SITES AND INVESTIGATORS ........................................ 40 
19.2 
ELECTRONIC CASE REPORT FORMS (ECRF) ................................................................. 40 
19.3 
DATA COLLECTION AND MANAGEMENT ....................................................................... 40 
19.4 
MAINTAINING RECORDS ..................................................................................................... 40 
19.5 
RECORD RETENTION ........................................................................................................... 41 
19.6 
INVESTIGATIONAL PRODUCT ACCOUNTABILITY ...................................................... 41 
19.7 
STUDY CLOSEOUT ................................................................................................................. 41 
19.8 
AUDITS AND INSPECTIONS ................................................................................................ 41 
19.9 
ANNUAL, INTERIM AND FINAL REPORT ........................................................................ 41 
20. 
STATISTICAL METHODOLOGY AND ANALYSIS ............................................................... 41 
20.1 
ANALYSIS POPULATIONS ................................................................................................... 41 
20.2 
DISPOSITION OF SUBJECTS ................................................................................................ 42 
20.3 
DEMOGRAPHIC AND OTHER SUBJECT CHARACTERISTICS .................................... 42 
20.4 
EXTENT OF EXPOSURE ........................................................................................................ 42 
20.5 
PRE-TRIAL AND CONCOMITANT MEDICATIONS ........................................................ 42 
20.6 
PRIMARY OUTCOME ............................................................................................................. 42 
20.7 
SAFETY AND OTHER OUTCOME MEASURES ................................................................ 43 
20.8 
MONITORING OF SAFETY AND PREGNANCY................................................................ 44 
APPENDIX 1. INVESTIGATOR RESPONSIBILITIES .................................................................... 45 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 7 of 47 
INVESTIGATIONAL PLAN SUMMARY 
 
Title: 
Evaluation of the Effectiveness, Safety and Tolerability of 
LevoCept (Levonorgestrel-Releasing Intrauterine System) for 
Long-Acting Reversible Contraception 
 
Protocol #: 
CMDOC-0022 
Version 4.0 / 18 October 2017 
 
Device Name: 
LevoCept Intrauterine Contraceptive; Levonorgestrel-Releasing 
Intrauterine System (referred to as LevoCept or Study Device 
throughout this document)  
 
Study Design:  
Prospective, multi-center, single-arm, open-label, Phase II clinical 
study 
 
Study Purpose: 
To evaluate the effectiveness, device placement, safety, and 
tolerability of LevoCept to support commencing a Phase III Clinical 
Study 
Study Duration: 
Subject enrollment will take approximately 5 months. Each subject 
will be followed for 12 months after device placement for the 
protocol endpoints, and then every 6 months thereafter for up to 
24 additional months for those subjects who wish to continue 
study device use. 
 
Enrollment: 
Up to 250 subjects will be consented, screened and have 
LevoCept placed, with a goal to have 2240 evaluable cycles at 12 
months.  It is planned that 225 of the 250 subjects will be within 
the 18-35 year age range, with a total of 2015 evaluable cycles. 
The remaining 25 subjects will be within the 36-40 year age range. 
 
Investigational  
Site Information:  
This study will be conducted at approximately 16 centers in the 
U.S. 
 
Follow-up:  
Physical assessment (office visit) will occur at weeks 6, 13, 26 and 
52 after placement, with monthly contact.  For those subjects who 
wish to continue study device use after 12 months, follow-up office 
visits will occur every 6 months with contact at the end of each 28-
day cycle beginning after the 52-week visit.  Additional visits will 
be conducted if necessary for safety issues.  
Follow-up after early study device removal: 
Subjects requesting LevoCept removal to become pregnant will be 
followed for either; six (6) months, until they decide to no longer 
try to conceive or they become pregnant, whichever comes first. 
All subjects in whom LevoCept is removed, for any reason, will be 
required to use an alternative contraceptive for the first two weeks 
following removal.  Hormonal contraceptive pills will be 
reimbursed by the sponsor as a contraceptive option during this 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 8 of 47 
time unless the subject has a MEC category 4 condition 
precluding their use.  
Study Population: 
Pre-menopausal women ages 18–40, at risk for pregnancy, who 
are interested in using only this intrauterine contraceptive for birth 
control will be eligible for this study. Subjects must provide written 
informed consent and meet the study subject selection criteria 
without any exclusions as outlined in the Clinical Investigation 
Plan (CIP). 
 
Primary Effectiveness Outcome: 
 
The primary outcome measure is effectiveness, evaluated as the 
absence of pregnancy with failures calculated by the Pearl Index 
and life-table analysis. All evaluable cycles prior to discontinuation 
or planned removal will be included in the primary analysis of 
effectiveness. 
 
Safety and Other Outcome Measures: 
 
 
 
Safety and other outcome measures include: 
Study Device Placement: 
- 
Ease of placement 
- 
Placement success 
 
Safety: 
- 
Serious Adverse Events  
- 
Adverse Events 
 
Tolerability: 
- 
Bleeding and spotting patterns 
- 
Discontinuation rate and reasons for discontinuation 
Subject Selection Criteria  
 
INCLUSION CRITERIA 
Subject must meet all of the following criteria to participate in this study:  
 
1. 
Between 18-40 years of age at the time of study initiation; 
1.1 
Enrollment will be targeted for 225 subjects aged 18-35 (for safety and 
effectiveness analyses) and an additional 25 subjects aged 36-40 (for 
safety only) (note: all subjects will be included in the analysis for device 
placement and tolerability); 
2. 
Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) for the 
last 3 months; 
2.1 
Based on patient history, when not on hormonal contraceptives; 
3. 
Sexually active with a male partner who has not had a vasectomy; 
4. 
Reasonably expected to have coitus at least once monthly during the study 
period. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 9 of 47 
5. 
In a mutually monogamous relationship of at least 3-6 months duration; 
6. 
Seeking to avoid pregnancy for the next 12 months; 
7. 
Willing to use the study device as the sole form of contraception; 
8. 
Willing to accept a risk of pregnancy;  
9. 
Subjects who are age 21 or older, at time of informed consent, must have a 
normal PAP or ASC-US with negative high risk HPV test result within the 
appropriate screen timeframe, and prior to LevoCept insertion;  
10. 
Able and willing to comply with all study tests, procedures, assessment tools and 
follow-up; and 
11. 
Able and willing to provide and document informed consent and Authorization for 
Release of Protected Health Information (PHI). 
 
EXCLUSION CRITERIA  
A subject will be excluded from participating in the study if any of the following 
conditions apply:  
 
1. 
Known or suspected pregnancy; or at risk for pregnancy from unprotected 
intercourse earlier in current cycle; 
2. 
Subject who anticipates separation from her partner for more than 1 cycle within 
the next 12 months; 
3. 
A previously inserted IUD that has not been removed by the time LevoCept is 
placed; 
4. 
History of previous IUD complications, such as perforation, expulsion, infection 
(pelvic inflammatory disease) or pregnancy with IUD in place.; 
5. 
Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 
months; 
5.1 
Must have had 2 normal menstrual cycles since the last injection; 
6. 
Planned use of any non-contraceptive estrogen, progesterone or testosterone 
any time during the 12 months of study participation; 
7. 
Postpartum, prior to a minimum of 6 weeks and complete uterine involution; 
8. 
Exclusively breastfeeding before return of menses; Lactating women will be 
excluded unless they have had have had two normal menstrual periods prior to 
enrollment. 
8.1 
Must have had 2 normal spontaneous menstrual cycles since delivery 
9. 
Unexplained abnormal uterine bleeding (suspicious for serious condition), before 
evaluation; Immediately post-septic abortion or puerperal sepsis (must wait a 
minimum of 3 months); 
10. 
Severely heavy or painful menstrual bleeding; 
11. 
Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically 
significant abnormal pap smear requiring evaluation or treatment. 
12. 
Any history of gestational trophoblastic disease with or without detectable 
elevated ß-hCG levels, or related malignant disease without an intervening 
normal pregnancy;  
13. 
Any congenital or acquired uterine anomaly that may complicate IUD placement, 
such as: 
13.1 
Submucosal uterine leiomyoma 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 10 of 47 
13.2 
Asherman’s syndrome 
13.3 
Pedunculated polyps 
13.4 
Bicornuate uterus 
13.5 
Didelphus or uterine septa 
14. 
Any distortions of the uterine cavity (e.g. fibroids), in the opinion of the 
investigator, likely to cause issues during insertion, retention or removal of the 
IUD;  
15. 
Known anatomical abnormalities of the cervix such as severe cervical stenosis, 
prior trachelectomy or extensive conization that, in the opinion of the investigator 
would prevent cervical dilation and study device placement;  
16. 
Current or recent (within the last 3 months) untreated acute cervicitis or vaginitis ; 
17. 
Known or suspected breast cancer or other progestin-sensitive cancer now or in 
the past;  
18. 
Known acute liver disease or liver tumor;  
19. 
Subjects who have an established immunodeficiency; 
20. 
High risk for STDs (e.g., multiple sexual partners); 
21. 
Known or suspected HIV infection or clinical AIDS; 
22. 
Known intolerance or allergy to any component of the LevoCept system; 
including nickel, silicone or tantalum; 
23. 
Subject had LevoCept placed previously or had 2 attempts at placement; 
24. 
Known or suspected alcohol or drug abuse within 12 months prior to the 
screening visit; 
25. 
Any general health or behavioral condition that, in the opinion of the Investigator, 
could represent an increased risk for the subject or would render the subject less 
likely to provide the needed study information. 
26. 
Subject is currently participating or has participated in another clinical study 
involving another investigational agent within 30 days of the planned LevoCept 
insertion date or is planning participation in another clinical trial with an 
investigational agent within 52 weeks (visit 6) after insertion. 
 
LevoCept Insertion Timing 
 
The following must be followed prior to LevoCept insertion to insure adequate 
contraception coverage: 
 
Subjects Using Any Hormonal Birth Control Method  
Subjects using any hormonal birth control method can have LevoCept placed on any day 
of the menstrual cycle. If the insertion occurs in the first 7 days of the cycle, the 
hormonal contraception can be discontinued after insertion. If the insertion occurs after 
the first 7 days of the menstrual cycle, the subject should continue using hormonal 
contraception for an additional 7 days. 
 
• 
Subjects using an implant (Implanon/Nexplanon) who have regular cycles, 
LevoCept should be inserted within seven days of onset of menses and the 
implant may be removed the same day. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 11 of 47 
• 
Subjects using an implant (Implanon/Nexplanon) who have irregular cycles or 
amenorrhea, LevoCept should be inserted and the implant should be removed 
seven days after IUD inserted 
• 
Subjects using an implant (Implanon/Nexplanon) with regular cycles but who are 
beyond seven days of menses, LevoCept may be inserted but removal of implant 
should occur after seven days. 
• 
Subjects using levonorgestrel IUD can have IUD removed and LevoCept placed 
on the same day. Insertion can occur on any day of the cycle. 
 
Subjects NOT Using Any Hormonal Birth Control Method (includes copper IUDs) 
Subjects NOT using hormonal contraception (including those currently using a copper 
IUD) must have the IUD inserted in the first 7 days of the menstrual cycle. Removal of a 
copper IUD and insertion of Levocept may occur on the same day as long as the 
procedure is performed within the first 7 days of the menstrual cycle.   
 
If pain is present with the subject’s current IUD, the subject should not be enrolled. 
 
STATISTICAL METHODS 
 
Effectiveness Outcome 
 
The primary efficacy population will include all subjects aged 18-35 who had a study 
device successfully placed, provided at least 1 day of e-diary data, and were not 
pregnant before the IUD was placed.  
 
Effectiveness will be evaluated as the absence of pregnancy during LevoCept use.  
Pregnancies judged to have occurred during study device use (determined by ultrasound 
and medical assessments), for which the estimated date of conception was within 7 days 
after study device removal or calculated date of expulsion, will be included in the per 
protocol analysis of pregnancies.   
 
The Pearl Index (and 95% confidence intervals) will be calculated for cycles in subjects 
aged 18-35 at the time of study device placement through the date of LevoCept removal 
or pregnancy, excluding the following cycles (unless the subject became pregnant in the 
cycle): 
• When back-up contraceptive or emergency contraceptive use was reported by the 
subject   
• When the subject denied having any intercourse.   
All pregnancies will be counted in the intent to treat analysis. 
 
Life table analyses will be used as further assessment of pregnancies.  Pregnancy rate 
will also be summarized annually for each of the 3 years and cumulatively. 
 
Safety and Other Outcome Measures 
 
LevoCept ease of placement, placement success, expulsions, and removal success will 
be descriptively summarized. 
 
Safety evaluations will be based on the incidence of adverse events and serious adverse 
events and by relationship to the study device or study device placement procedure.  

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 12 of 47 
Study device tolerability will be based on changes in bleeding and spotting patterns and 
study discontinuation (including reasons for discontinuation).  
Safety analyses will be based on the experience of all subjects who had attempted study 
device placement and provided any relevant data. Tolerability analyses will be based on 
the experience of all subjects who received a study device and provided any relevant 
data. 
 
Subjects will record frequency and intensity of vaginal bleeding through a daily e-diary. 
The number of bleeding or spotting days will be summarized for each cycle.  In addition, 
bleeding and spotting will each be summarized separately.  Bleeding analyses will 
include all subjects who had a study device placed and have at least 1 cycle where they 
were not pregnant and were providing bleeding-related e-diary data on the days in the 
reference period. 
 
In general, summaries of quantitative variables will include the sample size, mean, 
median, standard deviation, minimum, and maximum. For qualitative (categorical) 
variables the summaries will include the number and percentage of subjects in each 
category.   
 
SAMPLE SIZE  
 
No formal sample size calculations were performed for the study.  It is estimated that 
with 225 subjects enrolled with age 18-35, a 12-month Pearl Index of 0.6 (1 observed 
pregnancy), and 2,015 evaluable cycles, we will observe a 95% confidence interval for 
the 12-month Pearl Index of (0.1, 3.3).   
 
2,015 evaluable cycles assumes that in the overall study: 
• 
Each subject will average 10 evaluable cycles of LevoCept use 
• 
1% of subjects will not provide any e-diary data and will be excluded from the 
primary efficacy population 
• 
Subjects will not have intercourse or will use backup contraception in 9.2% of 
cycles 
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 13 of 47 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
AE 
Adverse Event 
BMI 
Body Mass Index 
BP 
Blood Pressure 
BUN 
Blood Urea Nitrogen 
BV 
Bacterial Vaginosis 
C 
Celsius 
CBC 
Complete Blood Count 
CCTN 
Contraceptive Clinical Trials Network 
CFR 
Code of Federal Regulations 
cm 
Centimeters 
CRF 
Case report forms 
Cu 
Copper 
CVR 
Contraceptive vaginal ring 
d 
Day 
DHHS 
Department of Health and Human Services 
dL 
Deciliter 
DSMB 
Data Safety Monitoring Board 
EC 
Emergency contraception 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ECYC 
Evaluable for Cycle Control 
EE 
Efficacy Evaluable 
EMR 
Electronic medical records 
ENDTX 
End of treatment 
EP 
Evaluable for Pregnancy 
F 
Fahrenheit 
FDA 
Food and Drug Administration 
FSH 
Follicle Stimulating Hormone 
g 
Gram 
GCP 
Good Clinical Practices 
GnRH 
Gonadotropin-Releasing Hormone 
hCG 
Human Chorionic Gonadotropin 
HD 
Health Decisions 
HPV 
Human Papillomavirus 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent-To-Treat 
IUD 
Intrauterine Device 
kg 
Kilograms 
L 
Liter 
LTFU 
Lost to follow up 
MedDRA 
Medical dictionary for regulatory activities 
MITT 
Modified Intent to Treat 
mg 
Milligrams 
mL 
Milliliter 
mm 
Millimeter 
NDA 
New Drug Application 
NIH 
National Institutes of Health 
N/A 
Not Applicable 
OC 
Oral Contraceptive(s) 
Pap Test 
Papanicolaou Test 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 14 of 47 
SAS 
Statistical Analysis Software 
SCCC 
Statistical and Clinical Coordinating Center 
SCRN 
Screening 
SD 
Standard Deviation 
SOP 
Standard Operating Procedure 
STD 
Sexually Transmitted Diseases 
TVUS 
Transvaginal ultrasound 
UNS 
Unscheduled 
US 
United States 
V 
Visit 
X 
Times 
WHO 
World Health Organization 
: 
To 
/ 
Per 
% 
Percent 
< 
Less than 
> 
Greater than 
≤ 
Less than or equal to 
≥ 
Greater than or equal to 
° 
Degrees 
± 
Plus or minus 
+ 
Plus 
 
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 15 of 47 
1. 
INTRODUCTION 
The LevoCept Intrauterine Contraceptive is designed as a birth control device. There are 
over 61 million US women in their child-bearing years, ages 15 to 44. Thirty-eight million 
(38M) use some form of contraception (62%). Thirty-one (31%) percent do not use or 
need contraception because they are either trying to get pregnant, are pregnant, are 
infertile or are not sexually active. Seven (7%) percent are at risk for unintended 
pregnancy since they are using no method1. 
Contraceptive options for those 38 million US women include permanent sterilization 
(tubal ligation or vasectomy in male partner), contraceptive implants, intrauterine 
devices, injections, pills, patches, vaginal rings, male and female condoms, other female 
barrier methods, vaginal spermicides, and behavioral methods such as coitus interruptus 
and fertility awareness. Of all these methods, oral contraceptives are used by 30% of 
sexually active women. The more effective methods, such as intrauterine contraceptives, 
are used by fewer than 10.3% of women and long acting reversible contraception 
(LARC) 11.6%.2  The contraceptive CHOICE project showed that the pill failure rate is 
over 25 times higher than levonorgestrel-releasing contraception.3,4  
Intrauterine contraceptives have high initial costs, so early discontinuation rates have 
profound impacts on their cost-effectiveness. The early rates of user dissatisfaction due 
to complications or side effects may be associated with the materials used in these 
devices and/or their design. The Copper T380A IUD has been associated with 
complaints of increased bleeding, inter-menstrual bleeding and cramping pain. The 
52mg LNG-IUS (Mirena®) is also associated with early complaints of irregular bleeding 
patterns, cramping pelvic pain and with amenorrhea.  
With high-unintended pregnancy rates in the U.S. (45%)1, additional effective, safe and 
long-acting reversible contraceptives are needed. An intrauterine device with 
levonorgestrel that achieves high contraceptive effectiveness and has improved 
mechanical advantages could offer an attractive option to women seeking effective 
protection against unintended pregnancy.  We believe the LevoCept Intrauterine 
Contraceptive embodies these advantages. 
 
 
2. 
STUDY DURATION 
Subject enrollment will take approximately 5 months. Each subject will be followed for 12 
months after device placement for the protocol endpoints, and then every 6 months 
thereafter for up to 24 additional months for those subjects who wish to continue study 
device use. 
 
                                                          
1Alan Guttmacher Institute Fact Sheets Oct 2013 (www.guttmacher.org):  
https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states#1 
2 Changes in Use of Long-Acting Reversible Contraceptive Methods Among U.S. Women, 2009-2012. 
Kavanaugh ML, Jerman J, Finer LB. 
Obstet Gynecol. 2015 Nov;126(5):917-27. doi: 10.1097/AOG.0000000000001094. 
PMID: 26444110 
 accessed August 11, 2014. 
3 Secura G, Alllsworth J, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible 
contraception. Am J Obstet Gynecol. 2010:20130;115 e1-7. 
4 Reeves MF, Zhao Q, Secura GM, Peipert JF. Risk of unintended pregnancy based on intended compared to actual contraceptive 
use. American Journal of Obstetrics & Gynecology. 2016. 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 18 of 47 
• 
Subjects using levonorgestrel IUD can have IUD removed and 
LevoCept placed on the same day. Insertion can occur on any day 
of the cycle. 
4.1.2  Subjects NOT Using Any Hormonal Birth Control Method 
(includes copper IUDs) 
Subjects NOT using hormonal contraception (including those currently 
using a copper IUD) must have the IUD inserted in the first 7 days of the 
menstrual cycle. Removal of a copper IUD and insertion of Levocept may 
occur on the same day as long as the procedure is performed within the 
first 7 days of the menstrual cycle.   
 
4.2 LevoCept Intrauterine Contraceptive (Dosage and Formulation) 
LevoCept contains 52 mg of Levonorgestrel which is released at a rate of 20 
micrograms per day. A single LevoCept design and dosage will be used in this 
study. LevoCept will be supplied by ContraMed, LLC.  For further details, see the 
LevoCept Investigator’s Brochure. 
4.3 LevoCept Supply and Administration 
Each LevoCept is preloaded in the inserter and packaged as a single use sterile 
system. Subjects will have LevoCept placed on “Day 1” of the trial.  LevoCept 
should be stored in its sterile sealed package until study device placement. 
See the Investigator’s Brochure for a more detailed LevoCept product 
description, and the LevoCept instructions (e.g. Clinician’s Quick Use Guide) for 
placement and removal instructions.   
4.4 LevoCept Storage and Accountability 
LevoCept should be stored at 25°C (77°F), with excursions permitted between 
15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. 
Study Device accountability, reconciliation and record maintenance are 
responsibilities that must be performed by the study site in accordance with all 
applicable regulatory requirements. Please refer to Appendix 1, Investigator 
Responsibilities for a detailed list of Investigator Responsibilities. All unused 
Study Devices will be stored for inventory and collection. Shipping procedures to 
return unused Study Devices are detailed in the Study Reference Manual. 
4.5 
LevoCept Dosage Modification 
All subjects will receive the same LevoCept device and dosage.  No Study 
Devices will be replaced if an expulsion or removal occurs.  
4.6 
Concomitant Therapy 
Concomitant medications are any prescription medications or over-the-counter 
preparations or routine medications used by the subject taken from the time the 
subject signs consent shall be documented until Study Exit.  Concomitant 
medications used as prior contraception or used to treat a prior cervical infection 
within 30 days of screening should also be reported.  All concomitant 
medications, including excluded therapies, must be documented in the 
Concomitant Medication eCRF. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 19 of 47 
4.7 
LevoCept Retention Compliance 
Subjects will be instructed on how to check for study device presence by feeling 
for the strings in the vagina.  Subjects will not be required to routinely check for 
study device presence, but if a subject believes the study device may have been 
expelled or is no longer in place, the subject can check for the study device string 
if desired.  If the subject does not feel the strings, feels more than the strings, or 
has expelled the study device, the subject should be instructed to call for an 
urgent study visit and refrain from having sex or use appropriate non-hormonal 
contraception until further evaluation is completed.  For detailed instructions 
regarding management of missing strings, refer to the Study Reference Manual.   
 
 
5. 
OBJECTIVES 
The scientific objective of this study is to evaluate the effectiveness, study device 
placement, safety, and tolerability of the LevoCept Intrauterine Contraceptive as birth 
control in parous and nulliparous women of child-bearing age.  
 
The purpose of the study is to obtain the safety and effectiveness data necessary to 
support initiation of a longer-term Phase III Pivotal Clinical Study for LevoCept. 
5.1 
Primary Outcome Measure 
The primary outcome measure is effectiveness, evaluated as the absence of 
pregnancy during LevoCept use. Failure will be calculated using the Pearl Index 
and by life table analysis. All evaluable cycles prior to discontinuation or planned 
removal will be included in the primary analysis of effectiveness. 
 
5.2 
Safety and Other Outcome Measures 
Safety and other outcome measures include: 
Study Device Placement: 
- 
Placement success 
- 
Ease of placement 
 
Safety; 
- 
Serious Adverse Events  
- 
Adverse Events 
 
Tolerability: 
- 
Bleeding and spotting patterns 
- 
Discontinuation rate and reasons for discontinuation 
 
 
6. 
BENEFITS AND RISKS 
6.1 
Potential Benefits 
No assurances or guarantees can be made regarding the benefits of LevoCept to 
the study subject. The potential benefits of LevoCept include that it is a hormonal 
contraceptive method that requires professional placement to be effective. 
6.2 
Potential Risks / Adverse Reactions 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 20 of 47 
The following adverse events have been reported in association with Mirena5, the 
most commonly used levonorgestrel IUD in the US. Serious adverse events and 
adverse events associated with the Mirena IUD may be relevant because it is 
also a 52 mg Levonorgestrel-Releasing Intrauterine System Contraceptive. It is 
not expected that the severity or frequency of any of the following events will be 
any different with use of the LevoCept.  These potential events are listed in 
alphabetical order, not in order of severity or frequency. See Investigators’ 
Brochure for more information.  
 
• 
Acne 
• 
Amenorrhea 
• 
Back pain 
• 
Breast cancer 
• 
Breast tenderness 
• 
Depression/depressive mood  
• 
Dysmenorrhea 
• 
Dyspareunia 
• 
Ectopic pregnancy  
• 
Embedment 
• 
Expulsion, partial or complete 
• 
Headache, migraine 
• 
Intrauterine pregnancy 
• 
Irregular menstrual bleeding 
• 
Leukorrhea 
• 
Ovarian cysts 
• 
Pain and cramping 
• 
Pelvic infection  
• 
Perforation 
• 
Sepsis 
• 
Vaginitis 
• 
Vasovagal reaction immediately after placement 
 
There may also be risks that are unanticipated at this time. 
 
6.3 
Minimization of Anticipated Risks 
Potential risks that may be associated with use of LevoCept have been minimized 
in this study by the following: 
a. Establishing eligibility criteria that exclude subjects who are at higher 
risk for experiencing an anticipated adverse event; 
b. Conducting extensive preclinical and clinical testing prior to the start of 
this Phase II clinical study;  
c. Conducting a risk analysis and incorporating mitigations to eliminate 
and/or reduce risks to as low as possible in accordance with ISO 
14971-Medical Devices – Application of risk analysis to medical 
devices 
d. Selecting investigators with proper level of training and experience in 
placing IUDs; 
                                                          
5 Prescribing Information, Mirena, Bayer Healthcare 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 21 of 47 
e. Ensuring adequate monitoring is performed to identify any safety issues 
associated with the study procedure and subjects; 
f. Regularly reviewing reported serious adverse events and adverse 
events throughout the study and taking appropriate medical measures 
to resolve the adverse events. 
 
6.4 
Safety Review 
The Medical Monitor will evaluate safety and pregnancies on an ongoing basis and 
significant findings will be addressed immediately.  A monthly safety and 
pregnancy review will occur with the Study Principal Investigator to review safety 
trends, including pregnancies. The medical monitor, the responsible project team 
and Sponsor personnel will review study drug-related findings periodically and at 
least bi-monthly. Additional details are located in the Medical Monitoring Plan. If 
the Medical Monitor identifies any safety issues that may alter the risk benefit ratio 
of the study product, the Medical Monitor will immediately inform the project team 
and the Sponsor. 
 
7. 
SELECTION AND TRAINING OF CLINICAL SITES AND INVESTIGATORS 
The study will be conducted at approximately 16 centers in the United States.  The 
primary requirements of selecting an Investigator for this study are: 1) experience and 
adequate training in a) IUD use and b) conduct of regulated clinical studies, 2) adequate 
facilities and equipment, 3) adequate patient volume, 4) appropriate personnel and site 
research staff to support the conduct of the study, and 5) commitment to safety and 
adherence to the investigational plan. 
 
Prior to acceptance of the site into this study, the Sponsor or its designee will conduct a 
site qualification visit (if applicable).  The site qualification visit will be scheduled to 
include time with the Principal Investigator, co-investigators, study coordinator, and other 
study personnel as available.  Areas of discussion include a review of personnel training, 
expertise, and FDA-regulated study experience, this study’s specific requirements, and a 
review of staffing and equipment availability and appropriateness. 
 
Prior to study implementation, the Study Monitor will ensure that study personnel: 
• 
Have appropriate training, facilities, time, and willingness to comply fully with 
the study requirements. 
• 
A central IRB will be used to review and approve the Investigational Plan 
wherever possible, but if it is not possible, the investigator will submit this 
Investigational Plan to the local IRB for appropriate review and obtain written 
approval for the conduct of the study prior to the initiation of any subject 
enrollment into this study. 
• 
Maintain all study correspondence, this Investigational Plan, and all related 
and required records on file at their facility. 
• 
Assume full responsibility for the study investigation at their individual medical 
practices, clinics, and medical facilities. The Study Monitor will create a 
written report of the pre-study site visit.  Resolution of any concerns and/or 
completion of any appropriate study activities identified during the pre-study 
visit will be documented by the Study Monitor, discussed with the Sponsor 
and submitted to the Investigator.   
• 
Complete any training required by the IRB regarding protection of human 
subjects. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 22 of 47 
• 
Complete training on use of the Case Report Forms (eCRFs) provided by 
ContraMed representative or designee. 
• 
Review and are familiar with LevoCept instructions (e.g. Clinician’s Quick Use 
Guide, Investigator’s Brochure). 
• 
Complete training with LevoCept, provided by a ContraMed representative or 
designee. 
 
Throughout the conduct of the study, the Sponsor and/or its designees will closely 
monitor each site for the following: 
 
• 
Compliance with the investigational plan 
• 
Meeting enrollment commitments 
• 
Accurate and timely submission of CRFs and additional data 
• 
Compliance with ICH E6 Good Clinical Practice (GCP) guidelines 
• 
Compliance with Declaration of Helsinki 
• 
Compliance with IRB and local regulatory requirements 
7.1 
Laboratories 
Local laboratories will be used for any lab tests performed.  No central labs will 
be used in this study. 
 
 
8. 
STUDY POPULATION  
The study population will be pre-menopausal women, at risk for pregnancy, who are 
interested in using an intrauterine contraceptive for birth control for at least 12 months.  
Subjects must provide written informed consent and meet the study entry criteria noted 
below. 
 
8.1 
Inclusion 
Subject must meet all of the following criteria to participate in this study:  
1. 
Between 18-40 years of age at the time of study initiation; 
1.1 
Enrollment will be targeted for 225 subjects aged 18-35 (for safety 
and effectiveness analyses) and an additional 25 subjects aged 36-40 (for 
safety only); (note: all subjects will be included in the analysis for device 
placement and tolerability); 
2. 
Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) 
for the last 3 months; 
2.1 
Based on patient history when not on hormonal contraceptives; 
3. 
Sexually active with a male partner who has not had a vasectomy; 
4. 
Reasonably expect to have coitus at least once monthly during the study 
period 
5. 
In a mutually monogamous relationship of at least 3-6 months duration 
6. 
Seeking to avoid pregnancy for the next 12 months; 
7. 
Willing to use the study device as the sole form of contraception; 
8. 
Willing to accept a risk of pregnancy;  

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 23 of 47 
9. 
Subjects who are age 21 or older, at time of informed consent, must have 
a normal PAP or ASC-US with negative high risk HPV test result within 
the appropriate screen timeframe, and prior to LevoCept insertion;  
10. 
Able and willing to comply with all study tests, procedures, assessment 
tools and follow-up; and 
11. 
Able and willing to provide and document informed consent and 
Authorization to Release Protected Health Information (PHI). 
 
8.2 
Exclusion 
A subject will be excluded from participating in the study if any of the following 
conditions apply:  
1. 
Known or suspected pregnancy; or at risk for pregnancy from unprotected 
intercourse earlier in current cycle; 
2. 
Subject who anticipates separation from her partner for more than 1 cycle 
within the next 12 months; 
3. 
A previously inserted IUD that has not been removed by the time 
LevoCept is placed; 
4. 
History of previous IUD complications, such as perforation, expulsion, 
infection (pelvic inflammatory disease) or pregnancy with IUD in place. 
5. 
Injection of any hormonal contraceptive (e.g., Depo-Provera) within the 
last 10 months; 
5.1 
Must have had 2 normal menstrual cycles since the last injection; 
6. 
Planned use of any non-contraceptive estrogen, progesterone or 
testosterone any time during the 12 months of study participation; 
7. 
Postpartum, prior to a minimum of 6 weeks and complete uterine 
involution; 
8. 
Exclusively breastfeeding before return of menses; Lactating women will 
be excluded unless they have had at least two normal menstrual periods 
prior to enrollment. 
8.1 
Must have had 2 normal spontaneous menstrual cycles since 
delivery;  
9. 
Unexplained abnormal uterine bleeding (suspicious for serious condition), 
before evaluation; Immediately post-septic abortion or puerperal sepsis 
(must wait a minimum of 3 months); 
10. 
Severely heavy or painful menstrual bleeding; 
11. 
Suspected or known cervical, uterine or ovarian cancer, or unresolved 
clinically significant abnormal pap smear requiring evaluation or 
treatment. 
12. 
Any history of gestational trophoblastic disease with or without detectable 
elevated ß-hCG levels, or related malignant disease without an 
intervening normal pregnancy;  
13. 
Any congenital or acquired uterine anomaly that may complicate IUD 
placement, such as: 
13.1 
Submucosal uterine leiomyoma 
13.2 
Asherman’s syndrome 
13.3 
Pedunculated polyps 
13.4 
Bicornuate uterus 
13.5 
Didelphus or uterine septa 
14. 
Any distortions (e.g. fibroids), in the opinion of the investigator, likely to 
cause issues during insertion, retention or removal of the IUD; 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 24 of 47 
15. 
Known anatomical abnormalities of the cervix such as severe cervical 
stenosis, prior trachelectomy or extensive conization that, in the opinion 
of the investigator would prevent cervical dilation and study device 
placement;  
16. 
Current or recent (within the last 3 months) untreated acute cervicitis or 
vaginitis; 
17. 
Known or suspected breast cancer or other progestin-sensitive cancer 
now or in the past; 
18. 
Known acute liver disease or liver tumor; 
19. 
Subjects who have an established immunodeficiency; 
20. 
High risk for STDs (e.g., multiple sexual partners); 
21. 
Known or suspected HIV infection or clinical AIDS; 
22. 
Known intolerance or allergy to any component of the LevoCept system; 
including nickel, silicone or tantalum. 
23. 
Subject had LevoCept placed previously or had 2 attempts at placement; 
24. 
Known or suspected alcohol or drug abuse within 12 months prior to the 
screening visit; 
25. 
Any general health or behavioral condition that, in the opinion of the 
Investigator, could represent an increased risk for the subject or would 
render the subject less likely to provide the needed study information. 
26. 
Subject is currently participating or has participated in another clinical 
study involving another investigational agent within 30 days of the 
planned LevoCept insertion date or is planning participation in another 
clinical trial with an investigational agent within 52 weeks (visit 6) after 
insertion. 
 
 
9. 
INFORMED CONSENT 
The person obtaining the informed consent shall: 
 
• 
Avoid any coercion of or undue influence of the candidate to participate; 
• 
Sustain all the candidate's legal rights; 
• 
Provide complete, detailed description of study events, procedures, follow up 
and costs/reimbursements using language that is non-technical and 
understandable to the candidate; 
• 
Ensure that the candidate understands risks and responsibilities; 
• 
Provide ample time for the candidate to consider participation, answer any 
questions and ensure that satisfactory answers are provided; 
• 
Include dated signatures of the candidate and of the clinical investigator (as 
applicable); 
• 
Shall ensure that all relevant requirements are met for witness signatures; 
• 
Ensure that the candidate understands the voluntary nature of participation 
and her ability to withdraw from the study at any time with no adverse impacts 
on her ability to obtain other services; 
• 
Ensure protection of the candidate’s confidentiality; and  
• 
Provide a copy of the Consent Form signed by the candidate and the person 
presenting the information for the candidate to take home. 
 
The process that leads to informed consent will be documented. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 25 of 47 
 
Each investigational site must provide the Sponsor or designee with a copy of the 
investigational site’s IRB approval letter (or Central IRB letter) and the IRB approved 
informed consent form, including the Authorization For Release Of Protected Health 
Information (PHI) form and the Subject Bill of Rights form (California only).  The Sponsor 
or designee must review and approve the IRB approved informed consent form prior to 
any subject enrollment. The Investigator or designee must review the informed consent 
form, PHI form and Bill of Rights form (if applicable) with the candidate and explain all 
study risks and benefits and answer all patient questions before obtaining the 
candidate’s signature on the informed consent form. All subjects must provide written 
informed consent in accordance with local law and approved by the site’s (or Central) 
IRB.   
 
 
10. 
ENROLLMENT 
A subject is considered enrolled into the study after signing the informed consent, PHI and 
Bill of Rights forms (if applicable) and being found eligible based on her history, physical 
examination, screening tests and LevoCept insertion attempt. If an eligible consented 
patient withdraws consent before insertion for any reason this would be considered a 
screen failure.  Enrollment is planned at approximately 250 subjects in a five-month period.   
 
 
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 27 of 47 
 
1. 
Pelvic exam for LevoCept string check 
2. 
Transvaginal Ultrasound performed at Visit 6 or Exit visit or if indicated 
3. 
First week of e-diary training, prior to LevoCept placement, to be used as training with the subject.  This e-diary 
data is not a part of data collection or analysis.  It is intended to ensure the subject understands how to 
complete the e-diary during the follow up period. 
4. 
Urine pregnancy test will be done 17 days after removal/study exit by the subject at home, with a follow up call 
by the study coordinator or PI required to document the results. 
Note: If LevoCept is removed before 52+2 weeks, Visit 6 activities should be completed for Exit Visit. 
5. 
Screening for cervical infections is required unless negative results have been obtained within three months of 
the screening visit.  
6. 
Current with ASCCP cervical cancer screening guidelines. for subjects who will be 21 or older at time of 
informed consent 
7. 
Insertion can occur without receipt of test results if there is no clinical evidence of infection.  
8. 
If a subject believes the study device may have been expelled or is no longer in place, the subject should call 
for an urgent study visit and refrain from having sex or use appropriate non-hormonal contraception until further 
evaluation is completed.  
9. 
For subjects exiting the study due to IUD expulsion: A urine pregnancy test will be done approximately 6-8 
weeks after the exit visit by the subject at home, with a follow up call by the study coordinator or PI required to 
document results 
 
 
12. 
STUDY PROCEDURES 
12.1 
Visit 1: Screening 
The following evaluations must be completed prior to the study device placement 
procedure:  
• 
Subject meets inclusion and exclusion criteria 
• 
Informed Consent, PHI and Bill of Rights forms signed 
• 
Demographics and baseline characteristics 
• 
Medical, surgical, gynecological and menstrual history 
• 
Vital signs (pulse, blood pressure, temperature) and weight 
• 
Height 
• 
General physical exam 
o General Appearance 
o Skin 
o HEENT 
o Thyroid 
o Lungs 
o Back 
o Breasts 
o Heart 
o Abdomen 
o Extremities 
o Neurological 
• 
Pelvic exam 
• 
Cervical cytology (current with ASCCP cervical cancer screening 
guidelines), for subjects who will be 21 or older at time of informed consent. 
A normal PAP or ASC-US with negative high-risk HPV test results must be 
received within the appropriate screen timeframe, and prior to LevoCept 
insertion. 
• 
Cervical infection tests (gonorrhea and chlamydia), unless negative results 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 28 of 47 
have been obtained within three months of the screening visit. Insertion 
can occur without receipt of test results if there is no clinical evidence of 
infection  
• 
Urine pregnancy test 
• 
Prior and concurrent medications 
• 
Need for contraception (review and discuss the subject’s need for 
appropriate contraception during the screening period)  
 
Subjects will be trained on e-diary use and completion.  E-diary instructions will be 
dispensed to the subject at this visit.  If the subject will be using a mobile device 
(e.g. cellphone or tablet) to complete the e-diaries, subject e-diary accessibility 
should be confirmed. E-Diary data from screening to the day of LevoCept 
placement is intended for training purposes and will not be included in the data 
analysis.  
12.2 
Visit 2: LevoCept Placement (Day 1) 
See Section 4.1 for LevoCept insertion timing instructions. Subjects must have a 
negative urine pregnancy test just prior to LevoCept placement.  Initiation of the 
LevoCept is consistent with standard IUD placement.  Refer to the Clinician’s 
Quick Use Guide and Investigator’s Brochure for specific instructions. 
 
If placement is unsuccessful, a second attempt may be made on the same day or 
within one (1) week following the first attempt.  If a second attempt is also 
unsuccessful, the subject will be discontinued early from the study.  The need for 
cervical dilation to facilitate placement of LevoCept will be left to the discretion of 
the investigator and subject; however, it is recommended that placement be tried 
first without prior cervical dilation.  Use of cervical dilation will be recorded on the 
case report form.  The need for pain control will also be left to the discretion of 
the investigator and subject.  Any medications given for pain control will be 
recorded on the Concomitant Medications case report form.   
 
Prior to LevoCept placement, the following evaluations will be completed: 
• 
Entry criteria confirmed  
• 
Vital signs and weight 
• 
Pelvic Exam 
• 
Pregnancy test, urine 
• 
Prior and concurrent medications 
• 
Any adverse events. 
Following LevoCept placement, the following will be performed: 
• 
LevoCept placement ease 
• 
LevoCept placement pain 
• 
LevoCept position (evaluated by Transvaginal Ultrasound) 
• 
Concomitant contraception 
• 
Need for contraception if LevoCept was not properly placed (If a subject 
believes the study device may have been expelled or is no longer in 
place, the subject should call for an urgent study visit and refrain from 
having sex or use appropriate non-hormonal contraception until further 
evaluation is completed. (See Section 4.7 for details) 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 29 of 47 
• 
Review the completed practice diaries and discuss with the subject any 
further training that is required and answer any questions the subject may 
have about how to correctly complete the diaries. 
• 
Instruct the subject to contact the site immediately if she thinks she has 
become pregnant. 
12.3 
Visits 3-6 Follow-up (Week 6±1w,13±2w, 26±2w and 52±2w/) 
The subject will return for follow up visits at preplanned intervals following 
placement of the LevoCept.  At these follow up visits, the following will be 
performed: 
• 
Vital signs and weight 
• 
Pelvic exam (string check) 
• 
Pregnancy test, urine 
• 
Transvaginal ultrasound (if indicated) 
• 
Concomitant contraception 
• 
Need for contraception (If a subject believes the study device may have 
been expelled or is no longer in place, the subject should call for an 
urgent study visit and refrain from having sex or use appropriate non-
hormonal contraception until further evaluation is completed. (See 
Section 4.7 for details) 
• 
Interval and concurrent medications 
• 
Adverse events 
• 
E-diary review with subject  
• 
Verify sexual activity and any back-up method is documented 
• 
Instruct the subject to contact the site immediately if she thinks she has 
become pregnant. 
Additionally, at the Visit 6/Week 52 visit, the following will also be 
performed: 
• 
Transvaginal ultrasound to document LevoCept position 
• 
General physical exam 
12.3.1 Exit Visit (Visit 2 – Visit 6/Week 52) 
In addition to the assessments in Section 12.3, the following will be performed for 
subject’s exiting the study between Visit 2 – Visit 6/Week 52: 
• 
Transvaginal ultrasound to document LevoCept position 
• 
General physical exam 
• 
Prior to removal of LevoCept, it should be determined if the subject has 
had vaginal intercourse (with intravaginal ejaculation) within the last 72 
hours. If confirmed, LevoCept removal and the Exit visit should be 
rescheduled. The subject should be instructed to avoid vaginal 
intercourse for 72 hours or more before LevoCept removal.  If 
rescheduling is not possible, the subject should be instructed not to have 
intercourse within 72 hours of LevoCept removal due to risk of pregnancy. 
The subject’s preferred method of contraception will be provided at the 
Exit visit.  
o If the subject elects a non-hormonal method of contraception, a 
14-day supply will be provided by the site.   

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 30 of 47 
o If the subject elects to use hormonal contraceptive pills as the 
preferred method of contraception, a one month supply of 
hormonal contraceptive pills will be provided to the subject by the 
site as a contraceptive option for the first two weeks following 
LevoCept removal.  
o The subject will also be provided with condoms to take with her as 
an extra precaution if the subject fails to acquire the contraception 
noted above. 
o In addition to the above, subjects who desire to have LevoCept 
removed immediately and have had vaginal intercourse (with 
intravaginal ejaculation) within 72 hours should also be provided 
with emergency contraception (e.g. ella®, Plan B One-Step®) 
• 
Subject should be reminded to avoid conception within 7 days after 
LevoCept removal. 
• 
LevoCept Removal 
o LevoCept removal ease 
o LevoCept removal pain 
• 
Urine pregnancy test will be done 17 days after removal/study exit by the 
subject at home, with a follow up call by the study coordinator or PI 
required to document results. 
12.3.2 Subjects Exiting the Study Due to IUD Expulsion: 
In addition to Sections 12.3 and 12.3.1, when a subject is exiting the study due to 
an IUD expulsion, the following will be performed: 
• 
A urine pregnancy test will be done approximately 6-8 weeks after the exit 
visit by the subject at home, with a follow up call by the study coordinator 
or PI required to document results. 
 
12.3.3 Monthly Contact (Up to 52 Weeks ± 1 w) 
Subjects will be contacted each month from the time of IUD insertion, to confirm 
completion of the monthly e-diary for: 
• 
The need for additional contraception (If a subject believes the study 
device may have been expelled or is no longer in place, the subject 
should call for an urgent study visit and refrain from having sex or use 
appropriate non-hormonal contraception until further evaluation is 
completed. (See Section 4.7 for details); 
• 
Use of emergency contraception; 
• 
Documentation of menstrual and intermenstrual bleeding;  
• 
Documentation of menstrual pain or cramping 
 
Additionally, the following will occur during the monthly contacts: 
• 
Assess if there have been any adverse events since the last contact; 
• 
Use of concomitant medications;  
• 
Collection of any missing diary information (frequency of intercourse, pain 
with intercourse and use of concomitant or emergency contraception); 
and 
• 
Resolution of any prior serious adverse events or adverse events. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 31 of 47 
12.4 
Long-term Follow-up, post 52-weeks visit (Every 6 Months: Months 
18-30 (±4wks) and 3 yrs (-3wks/+4wks) 
At 52 weeks, subjects will be allowed to continue with the study device with a 
follow-up office visit every 6 months for a maximum of three years post study 
device placement. During these visits, the following will be performed: 
• 
Vital signs and weight 
• 
Pelvic exam (string check) 
• 
Transvaginal ultrasound If unable to confirm IUD placement by string 
check or if indicated 
• 
Pregnancy test, urine 
• 
Interval and concurrent medications 
• 
Adverse events 
• 
Concomitant contraception 
• 
Need for contraception (If a subject believes the study device may have 
been expelled or is no longer in place, the subject should call for an 
urgent study visit and refrain from having sex or use appropriate non-
hormonal contraception until further evaluation is completed. (See 
Section 4.7 for details) 
• 
Verify sexual activity and any back-up method is documented 
• 
Instruct the subject to contact the site immediately if she thinks she has 
become pregnant. 
12.4.1 End of Each 28-day Cycle Contact (Post 52 Weeks + 1 w) 
Subjects will be contacted (e.g. phone calls, e-mail or text message) at the end of 
each 28-day cycle, beginning after the 52-week visit. Cycles are determined from 
the day of LevoCept insertion: 
o Verify sexual activity 
o Document any back-up contraception methods 
12.4.2 Exit Visit (Post Visit 6/Week 52 – Year 3) 
In addition to the assessments in Section 12.4, the following will be performed for 
subject’s exiting the study between Visit 6/Week 52 and year 3: 
• 
Transvaginal ultrasound to document LevoCept position 
• 
General physical exam 
• 
Prior to removal of LevoCept, it should be determined if the subject has 
had vaginal intercourse (with intravaginal ejaculation) within the last 72 
hours. If confirmed, LevoCept removal and the Exit visit should be 
rescheduled. The subject should be instructed to avoid vaginal 
intercourse for 72 hours or more before LevoCept removal.  If 
rescheduling is not possible, the subject should be instructed not to have 
intercourse within 72 hours of LevoCept removal due to risk of pregnancy. 
The subject’s preferred method of contraception will be provided at the 
Exit visit.  
o If the subject elects a non-hormonal method of contraception, a 
14-day supply will be provided by the site.   
o If the subject elects to use hormonal contraceptive pills as the 
preferred method of contraception, a one month supply of 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 32 of 47 
hormonal contraceptive pills will be provided to the subject by the 
site as a contraceptive option for the first two weeks following 
LevoCept removal.  
o The subject will also be provided with condoms to take with her as 
an extra precaution if the subject fails to acquire the contraception 
noted above. 
o In addition to the above, subjects who desire to have LevoCept 
removed immediately and have had vaginal intercourse (with 
intravaginal ejaculation) within 72 hours should also be provided 
with emergency contraception (e.g. ella®, Plan B One-Step®) 
• 
Subject should be reminded to avoid conception within 7 days after 
LevoCept removal. 
• 
LevoCept Removal 
o LevoCept removal ease 
o LevoCept removal pain 
• 
Urine pregnancy test will be done 17 days after removal/study exit by the 
subject at home, with a follow up call by the study coordinator or PI 
required to document results. 
12.4.2 Subjects Exiting the Study Due to IUD Expulsion: 
In addition to Sections 12.4 and 12.4.1, when a subject is exiting the study due to 
an IUD expulsion, the following will be performed: 
• 
A urine pregnancy test will be done approximately 6-8 weeks after the exit 
visit by the subject at home, with a follow up call by the study coordinator 
or PI required to document results. 
12.5 
Early Discontinuation Visit 
If a subject requests LevoCept removal because of an adverse event, the Study 
Exit Visit described in Section 12.3 above should be completed and documented 
on the CRF at the time of LevoCept removal.  The subject will be followed until 
resolution of the event or 30 days after removal, whichever occurs first.  Subjects 
experiencing an ongoing adverse event will continue to receive the appropriate 
follow-up medical care. 
 
If a subject requests early discontinuation and LevoCept removal to become 
pregnant, the Study Exit Visit should be completed and documented on the CRF 
at the time of LevoCept removal.  Additionally, subjects shall be followed for either; 
six (6) months, until they decide to no longer try to conceive or they become 
pregnant, whichever comes first. Outcome data regarding subject’s ability to 
conceive, or the decision to no longer try to become pregnant will be collected via 
subject contact and documented.   
12.6 
Unscheduled Visits 
Unscheduled visits must be documented on an unscheduled visit CRF.  Medical 
evaluations will be conducted as indicated by the reason for the unscheduled 
visit. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 33 of 47 
12.7 
Emergency Contraception 
If the subject suspects the LevoCept has expelled, she should contact the study 
site immediately. The subject should be counselled to avoid intercourse until an 
exam can confirm expulsion. Emergency contraception may be administered, 
according to product labelling, if the subject suspects expulsion has occurred and 
an act of intercourse might be unprotected, and she does not want the risk of 
pregnancy.  If the subject is subsequently found to have an in-situ IUD and 
desires to continue in the study, the cycle during which she used EC will not be 
included in the analysis unless the subject conceives.  If the IUD is expelled, she 
will be exited from the study and followed for 6-8 weeks for occurrence of 
pregnancy.   
12.8 
Lost to Follow-up 
A subject should not be considered “lost to follow-up” until the site has made at 
least three contact attempts (e.g. phone calls, e-mail or text message) and a 
certified letter is sent. The date of the certified letter or last attempted contact by 
the site is the subject’s exit date, whichever is later. The End of Trial and any 
Adverse Event or Concomitant Medication eCRFs should be submitted within a 
week of the subject’s lost to follow-up date. The site should continue attempts to 
contact the subject monthly for an additional 3 months to bring the subject back 
to remove the LevoCept IUD. 
If after a subject is determined to be lost to follow-up and subsequently becomes 
available again, and the Principal Investigator determines she is a fit study 
subject, she can re-join the study. 
 
13. 
Diaries 
Subjects will be instructed to complete diaries daily.  Diaries are designed to collect the 
following information for each day of the 28-day cycle: 
• 
Day of cycle 
• 
Absence or presence of menstrual or other bleeding (none, spotting, normal or 
heavy) 
• 
LevoCept expulsion (yes, no, suspected) 
• 
Usage of additional birth control methods and type of birth control used 
• 
Presence of menstrual pain or cramping 
• 
Frequency of intercourse 
• 
Pain with intercourse 
 
14. 
CONCOMITANT MEDICATIONS 
Concomitant medications include any medication or health product (any prescription 
medications or over-the-counter preparations) taken from the time the subject signs the 
informed consent documents until Study Exit.  Concomitant medications used as prior 
contraception or used to treat a prior cervical infection within 30 days of screening 
should also be reported.  All concomitant medications, including excluded therapies, 
must be recorded appropriately on the eCRF.   
 
 
15. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
During the study, the Investigator or study site personnel will be responsible for querying 
and recording adverse events (AEs) and serious adverse events (SAEs), as detailed 
below. For the Sponsor to fulfill safety assessment obligations, the Investigator must 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 34 of 47 
report all SAEs to the Study Sponsor, whether or not they result from study participation, 
within 24 hours of learning of the event. 
15.1 
Definition of a Serious Adverse Event 
A serious adverse event (SAE) is any adverse event occurring within the 
timelines specified in the protocol that results in any of the following outcomes: 
• 
Death; 
• 
Life-threatening meaning that the patient was at immediate risk of 
death from the event at the time that the event occurred. It does not 
include an event, which hypothetically might have caused death if it 
occurred in a more severe form. 
• 
Inpatient hospitalization or prolongation of existing hospitalization; 
• 
Persistent or significant disability/incapacity; 
• 
Congenital anomaly/birth defect in the offspring of a subject who 
received study device; or 
• 
Important medical events that may not result in death, be immediately 
life-threatening, or require hospitalization, may be considered an SAE 
when, based upon appropriate medical judgment, they may 
jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 
Examples of serious adverse events include, but are not limited to: 
intensive treatment in an emergency room, hospitalization for any 
reason, and extensive treatment at home for an adverse event.  An 
ectopic pregnancy is considered a serious adverse event. 
 
15.2 
Definition of An Adverse Event  
An adverse event is any untoward medical occurrence in a clinical investigation 
subject administered an investigational product and which does not necessarily 
have to have a causal relationship with this treatment. An AE can, therefore, be 
any unfavorable and unintended sign (that could include a clinically significant 
abnormal laboratory finding), symptom, or disease temporally associated with the 
use of a medicinal product, whether or not considered related to the medicinal 
product. 
 
• 
Any medical condition or clinically significant laboratory abnormality 
with an onset date before the first date of attempted study device 
placement is usually considered to be pre-existing, and should not be 
documented in the eCRF as an AE, unless there is an increase in 
frequency or intensity of that AE, but should be recorded as medical 
history. 
• 
Any AE (i.e., a new event or an exacerbation of a pre-existing 
condition) with an onset from the first attempt of study device 
placement through Study Exit should be recorded as an AE on the 
eCRF. All AEs must be recorded on the AE eCRF regardless of the 
severity or relationship to study device. It is important that 
Investigators also report all AEs that result in expulsion or removal of 
the investigational product being studied, whether serious or non-
serious. 
 
Pregnancy is an outcome, and not an adverse event in this study. 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 35 of 47 
15.3 
Causality: Serious Adverse Event and Adverse Event Relationship 
to Study Treatment 
 
The Investigator will assess the relationship of the SAE and AE to study device 
placement procedure (procedure) or study device by using the following general 
guidelines: 
 
Not Related: A causal relationship between the study device and the AE can be 
ruled out (e.g., based on the temporal sequence, absence of a reasonable 
pathophysiological mechanism, or direct evidence of actual cause).  
 
Unlikely related: A clinical event, including laboratory test abnormality, with a 
temporal relationship to procedure or study device initiation which makes a 
causal relationship improbable, and in which other drugs, chemicals or 
underlying disease provide plausible explanations. 
 
Probably Related: A clinical event, including laboratory test abnormality, with a 
reasonable time sequence to first attempt of study device placement, unlikely to 
be explained by concurrent disease or other drugs or chemicals.  Information on 
drug withdrawal may be lacking or unclear. 
 
Related: A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to first attempt of study device placement, cannot be attributed to 
concurrent disease or other medical devices, drugs, or chemicals, and which 
follows a clinically reasonable response on withdrawal. 
 
15.3.1 Clarification of Adverse Events Related to Study Procedures 
Any untoward event that occurs from the beginning of the study device 
placement procedure until completion of placement, or from the beginning 
of the removal procedure until the completion of removal, will be reported 
as an AE. The AE should be recorded on the AE eCRF with a causality 
assessment of “related to study device placement procedure.” If the AE 
also meets the criteria for an SAE, an SAE eCRF should be completed 
and submitted to Sponsor. 
 
15.4 
Serious Adverse Event and Adverse Event Severity 
The Investigator will assess the severity of the AE using the following general 
guidelines: 
 
• 
Mild: An AE that is usually transient, requiring no special treatment, 
and does not interfere with the subject’s daily activities. 
• 
Moderate: An AE that introduces a low level of inconvenience or 
concern to the subject and may interfere with daily activities, but is 
usually ameliorated by simple therapeutic measures. 
• 
Severe: An AE that interrupts a subject’s usual daily activity and 
typically requires systemic drug therapy or other treatment (a severe 
AE may not necessarily qualify as an SAE). 
• 
Life-threatening: An AE that put the subject at immediate risk of 
death from the event as it occurred. This does not include an event 
that might have led to death if it had occurred with greater severity. 
• 
Fatal: An AE that was the cause of the subject’s death 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 36 of 47 
15.5 
Adverse Event Outcome 
The Investigator will categorize the outcome of each SAE and AE according to 
the definitions below: 
 
• 
Resolved: The subject recovered from the SAE or AE. 
• 
Resolved with sequelae: a condition whereby the consequences of a 
disease or injury include lingering effects. 
• 
Ongoing: At the time of the last assessment, the event is ongoing, 
with an undetermined outcome. Note: Ongoing SAEs and AEs are not 
considered resolved as a result of death and no SAE or AE stop date 
should be recorded for an AE that is ongoing at the time of death. 
• 
Fatal: Adverse Event directly caused death. The Sponsor may 
request that the Investigator perform or arrange for the conduct of 
supplemental measurements and/or evaluations. If a subject dies 
during participation in the study or during a recognized follow-up 
period, the Sponsor should be provided with a copy of any post-
mortem findings, including histopathology.  Note: Death is an outcome 
of an adverse event and not an adverse event in itself. All reports of 
subject death should include an adverse event term (other than 
“Death”) for the cause of the death. 
 
Since reporting of an SAE is required within 24 hours of discovery, Death can be 
reported as an initial event term and updated to the final diagnosis in a follow-up 
report. If an adverse event term is not provided, the Investigator will be queried to 
obtain the cause of death. Only in the rare occurrence that no verbatim 
description of an adverse event can be obtained from the investigative site will 
“Death – Unknown Cause” be used as the event term. 
 
The Investigator should attempt to establish a diagnosis of the event based on 
the signs, symptoms and/or other clinical information. In such cases, the 
diagnosis should be documented as the AE (and SAE if serious) and not the 
individual signs/symptoms. 
 
In the case of abnormal labs or diagnostic tests judged to be clinically significant 
by the Investigator a diagnosis, if known, or clinical signs or symptoms if the 
diagnosis is unknown, rather than the clinically significant laboratory finding or 
abnormal assessment, should be used to complete the AE or SAE eCRF. If no 
diagnosis is known and clinical signs or symptoms are not present, then the 
abnormal finding should be recorded on the AE or SAE eCRF. If an SAE report is 
completed, pertinent laboratory data should be recorded on the SAE eCRF, 
preferably with baseline values and copies of laboratory reports. 
 
15.6 
Prompt Reporting of SAEs to Sponsor 
The Sponsor has requirements for reporting serious adverse events to regulatory 
agencies for a drug under clinical investigation. The Sponsor must be notified 
within 24 hours of discovery if the Investigator determines that an adverse 
event meets the protocol definition of an SAE. 
 
All SAEs occurring from the time of LevoCept insertion through study exit require 
immediate reporting to the Sponsor. Investigators should not wait to receive 
additional information to fully document the event prior to notifying the Sponsor 
but should provide as much relevant information as immediately available. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 37 of 47 
Further details of the event can be provided as they become available. The 
procedures for reporting SAEs are as follows: 
 
• 
Complete the “Serious Adverse Event Report” form; 
• 
Submit the completed form to Sponsor; 
• 
For fatal or life-threatening events, also submit copies of hospital case 
reports, autopsy reports, and other documents when requested and 
applicable; 
• 
The Sponsor may request additional information from the Investigator 
to ensure the timely completion of accurate safety reports; 
• 
Any fatal or life-threatening events should also be reported 
immediately by telephone to Sponsor; 
• 
The SAE eCRF should be completed as thoroughly as possible and 
signed by the Investigator before transmittal to Sponsor. It is very 
important that the Investigator provides an assessment of the causal 
relationship between the event and the study device at the time of the 
initial report; and 
• 
The Investigator, or responsible person according to local 
requirements, must comply with the applicable local regulatory 
requirements concerning the reporting of SAEs to regulatory 
authorities and the IRB. 
15.7 
Clinical Laboratory Abnormalities and Other Abnormal Assessments 
as Adverse Events and Serious Adverse Events 
Abnormal laboratory findings (e.g., clinical chemistry, hematology) or other 
abnormal assessments (e.g., electrocardiogram, X-rays, vital signs) per se are 
not reported as AEs. However, abnormal findings that are deemed clinically 
significant (i.e., associated with signs and/or symptoms or requiring therapeutic 
intervention) must be recorded as AEs if they meet the definition of an adverse 
event (and recorded as an SAE if they meet the criteria of being serious) as 
described previously. Clinically significant abnormal laboratory or other abnormal 
findings that are detected after study device placement or that are present at 
baseline and worsen following the placement of LevoCept are included as AEs 
(or SAEs if serious). 
 
The Investigator should exercise his or her medical judgment in deciding whether 
an abnormal laboratory finding or other abnormal assessment is clinically 
significant. A clinically significant laboratory abnormality in the absence of clinical 
symptoms may also jeopardize the subject and may require intervention to 
prevent immediate consequences (e.g., a markedly high serum potassium 
concentration may not be accompanied by arrhythmia, yet be of a magnitude to 
require potassium-binding resin administration to prevent such sequelae). 
Subjects should undergo repeat testing of clinically significant abnormal 
laboratory findings as soon as they are recognized. 
 
15.8 
Documenting Adverse Events 
Any AE occurring from the beginning of the study device placement procedure 
through Study Exit must be documented in the subject’s study records and on the 
AE eCRF. SAEs that occur during the study must be documented in the subject’s 
study record, on the AE eCRF and on the SAE eCRF as appropriate. 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 38 of 47 
The investigator’s assessment of causality, severity and status of the adverse 
event must be documented. When a causality assessment is provided for a 
serious adverse event, it is important to include a rationale for the assessment so 
that a better understanding of the reported event can be compiled. The rationale 
should be accompanied by all available supporting evidence, including relevant 
laboratory tests, histopathology evaluations and the results of other diagnostic 
procedures. The Investigator’s rationale with supporting evidence is valuable 
when Sponsor performs a cumulative analysis of similar events. 
 
15.9 
Follow-up of Adverse Events and Serious Adverse Events 
All AEs and SAEs must be followed until resolution, the condition stabilizes, 30 
days post study device removal, or the subject dies or is lost to follow-up 
(including withdrawal of consent), whichever occurs first. The Investigator is 
responsible to ensure that follow-up includes any supplemental investigations as 
may be indicated to elucidate as completely as practical the nature and/or 
causality of the AE/SAE. This may include additional laboratory tests or 
investigations, histopathologic examinations, or consultation with other health 
care professionals. Follow-up information should be submitted to the Sponsor in 
a timely many as the information is obtained. 
 
15.10 Clarification in Reporting of Deaths 
All subject deaths (regardless of relationship to study device) should be reported 
that occur from the beginning of study device placement through Study Exit. The 
information should be recorded on the Subject Death form and the SAE eCRF. 
 
15.11 Post-Study Treatment Reporting Requirements 
For all enrolled subjects, all AEs and SAEs, regardless of cause or relationship, 
that occur from the beginning of study device placement through Study Exit 
require reporting to the Sponsor.  In addition, if the Investigator learns of any 
SAE at any time after a subject has had the study device removed, and such 
event seems reasonably related to study drug, the Investigator should 
immediately notify the Sponsor. 
 
15.12 Study Device Malfunction 
Should the study device not perform mechanically as expected, it is essential that 
it be returned to the study Sponsor for assessment.   
 
 
16. 
PROTOCOL VIOLATIONS and DEVIATIONS 
Except in the event of a medical emergency or where it is necessary to protect the 
safety, rights or welfare of the study subject, any changes to the protocol will require 
written approval of ContraMed LLC or designee.  Violations or deviations from the 
Clinical Investigational Plan to protect the health and safety of the subject will be 
reported to the IRB and as required by local regulations. All protocol violations or 
deviations will be recorded, tracked and reviewed periodically by ContraMed and its 
designee, according to process established prior to first patient enrolled. A protocol 
violation or deviation may be requested in advance of implementation and will be 
reviewed for approval by ContraMed or its designee, or a violations/deviation may be 
identified after the fact, by the Investigator, ContraMed, or the monitoring staff.  
Investigators will be asked to provide an explanation for the all violations and deviations 
identified. ContraMed, or designee, will be responsible for analyzing deviations and may 
implement corrective actions as necessary.   

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 39 of 47 
 
 
17. 
SUBJECT CONFIDENTIALITY 
At all times throughout this study, all parties shall strictly observe the confidentiality of 
subject’s health information.  All data shall be secured against unauthorized access.  
Each subject participating in this study will have consented to allow access to her data, 
as described during the informed consent process and documented in the signed 
informed consent form.  Each subject will also sign an Authorization For Release of 
Protected Health Information (PHI) form granting ContraMed and its designees access 
to her medical records, should she receive medical care from non-study sites where she 
gets care (e.g., emergency room, urgent care, etc.).Each subject will be assigned a 
unique identifier.  All eCRFs will be tracked, evaluated, and stored using only this unique 
identifier.  HIPAA guidelines and regulations will be followed.  
 
The Investigator will maintain a confidential study subject list identifying all enrolled 
subjects. This list will contain the assigned study subject’s unique identifier and name.  
The Investigator bears responsibility for keeping this list confidential.  This list will not be 
provided to the study Sponsor and is only to be used at the study center. 
 
Monitors and auditors will have access to the study subject list and other personally 
identifying information of study subjects to ensure that data reported in the eCRFs 
corresponds to the person who signed the consent form and the information contained in 
the original source documents.  Such personal identifying information may include, but 
not limited to, the subject’s name, address, date of birth, gender, race and medical 
record number. 
 
In an effort to protect subject confidentiality, any source documents copied for monitoring 
purposes by the Sponsor or designee will be identified using the subject’s assigned 
unique identifier and personal identifying data will be obscured. 
 
 
18. 
PREGNANCY DETERMINATION AND FOLLOW UP 
Suspected pregnancy will be confirmed with a urine pregnancy test.  A positive 
urine test will be confirmed by a serum test and/or ultrasound as is appropriate.  
Pregnancies will be promptly confirmed and dated by ultrasound evaluation and 
medical assessment as needed. Presence or absence of the study device will 
also be determined by ultrasound.  Removal of the study device, if in place, will 
be performed as deemed appropriate by the study physician and upon obtaining 
subject consent (note: removal itself may be performed by another clinician, such 
as a nurse practitioner).  Consideration of study device removal should include 
the following standard of care criteria: If the subject has an intrauterine 
pregnancy in the first trimester and the study device is seen to be in the uterine 
cavity or cervix on ultrasound, remove the study device if the retrieval threads are 
visible. If the retrieval threads are not accessible, the IUD should remain in the 
uterus until delivery (abortion or term).  
Subjects will be counseled and followed through completion of pregnancy, and 
the clinical outcome will be recorded.   
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 40 of 47 
19. 
DATA MONITORING AND QUALITY CONTROL 
19.1 
Monitoring of Clinical Sites and Investigators 
Periodic monitoring visits will be made at the investigational site throughout the 
clinical study to ensure that the Investigator obligations are fulfilled and all 
applicable regulations and guidelines are being followed. These visits will ensure 
that the facilities remain acceptable, the investigational plan is being followed, the 
IRB and local authorities have been notified of approved investigational plan 
changes as required, complete records are being maintained, appropriate and 
timely reports have been made to the Sponsor and/or its designees and the IRB, 
study device and study device inventory are controlled and the Investigator is 
carrying out all agreed upon activities. The Sponsor will reserve the right to 
remove either the Investigator or the investigational site from the study for 
noncompliance with the investigational plan or regulations.  See monitoring plan 
for full details. 
19.2 
Electronic Case Report Forms (eCRF) 
Electronic case report forms (eCRFs) will be used to collect all subject data 
during the study 
 
The Investigator is responsible for the accuracy and completeness of all data on 
the eCRFs. 
 
Sponsor personnel or designee will review completed eCRFs at regular intervals 
throughout the study. Information on the eCRFs will be compared to information 
originally recorded on source documents related to the study.  Information on the 
eCRF must match the same information on the source documents or a data 
query will be issued.   
 
The Sponsor will use the study data for statistical and tracking purposes and will 
treat the information as confidential. 
19.3 
Data Collection and Management 
Qualified study staff at the investigational site will perform primary data collection. 
The Sponsor monitors and/or designees will perform clinical study monitoring of 
100% of the subjects who pass screening evaluations and undergo LevoCept 
placement.  This monitoring will include review of eCRF data with verification to 
the source documentation. 
 
All eCRFs will be reviewed for completeness, validity, and consistency. Queries 
will be generated and resolved with the sites and all protocol deviations will be 
recorded on the eCRF.  
19.4 
Maintaining Records 
The Sponsor and/or its designees will maintain copies of correspondence, data, 
shipment of study devices, adverse study device effects and other records 
related to the clinical study. The Sponsor will maintain records related to the 
signed Investigator agreements. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 41 of 47 
19.5 
Record Retention 
All study records and reports will remain on file for a minimum of two years (or 
longer if local law or clinic administration requires) after the latter of the following 
two dates: 2 years after a marketing application is approved, or if an application 
is not approved, until 2 years after shipment and delivery of the study device for 
investigational use is discontinued and FDA has been so notified. Study records 
should only be discarded upon written notification from the Sponsor. All records 
and reports are subject to inspection at any time. 
19.6 
Investigational Product Accountability 
The Sponsor or designee shall ship investigational study devices only to qualified 
investigators. The Investigator shall maintain adequate records of the receipt and 
disposition of all investigational study devices.  The Investigator shall return any 
unused devices, opened or unopened, to the Sponsor or its designees when the 
study has completed.   
19.7 
Study Closeout 
Upon completion of the clinical study (when all subjects enrolled have completed 
the last required visit and the eCRFs and queries have been completed), the 
Sponsor and/or its designees will notify all investigational sites of closeout. 
Unused study devices, and any unused study materials will be collected and 
returned to the Sponsor and/or its designees.   
19.8 
Audits and Inspections 
The Investigator will permit access to original medical records and provide all 
requested information in the event that the Sponsor and/or its designees or 
national regulatory authorities initiate any audits or inspections.  In the case that 
it is a non-Sponsor initiated audit, the investigator must contact the Sponsor as 
soon as possible after notification of intent to audit. 
19.9 
Annual, Interim and Final Report 
Annual, interim and final reports will be completed in accordance with the 
applicable local and federal regulations.  A final report will be completed even if 
the study is prematurely terminated.  
 
 
20. 
STATISTICAL METHODOLOGY AND ANALYSIS 
A detailed statistical analysis plan will be finalized prior to locking the database to 
conduct the statistical analysis in accordance with the methods presented below. 
20.1 
Analysis Populations 
The following analysis populations will be created: 
All Enrolled: All subjects enrolled into the study. 
Intent to Treat (ITT) / Safety:  All enrolled subjects who underwent the study 
device placement procedure, regardless of whether the study device was 
successfully placed or not. 
Evaluable for Pregnancy (EP):  
Subjects must meet requirements 1 and 2 to be EP. Subjects must also meet 
either requirement 3 or requirement 4 to be EP. 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 42 of 47 
1. between 18 to 35 years of age (inclusive) at enrollment 
2. at least one report of pregnancy status after being enrolled 
AND  
3. have at least 1 cycle of e-diary with intercourse and without any 
backup contraception or emergency contraception (EC) 
OR 
4. became pregnant while LevoCept was in place.  
Evaluable for Cycle Control (ECYC):  all subjects Evaluable for Pregnancy with at 
least one cycle for which: A) a pregnancy did not occur; and B) there is bleeding 
related e-diary data. 
20.2 
Disposition of Subjects 
The number of subjects who are enrolled, complete scheduled study visits and 
who complete the study will be summarized for the All Enrolled population. 
20.3 
Demographic and Other Subject Characteristics 
Subject demographics and pre-treatment characteristics will be summarized for 
the All Enrolled Population. 
20.4 
Extent of Exposure 
Exposure (number of subjects with LevoCept placed and number of cycles of 
use) to the study device will be summarized.  
20.5 
Pre-Trial and Concomitant Medications 
Concomitant medications include any medication or health product (any 
prescription medications or over-the-counter preparations) taken during the 
study.  Pre-trial medications include any contraception or medication used to 
treat a prior cervical infection taken within 30 days of screening.  The number 
and percentage of subjects using medications, as captured on the Concomitant 
Medication eCRF, will be tabulated according to the medication’s World Health 
Organization Anatomical Therapeutic Drug Class and Generic Term.  Pre-trial 
and concomitant medications will be presented separately. 
20.6 
Primary Outcome 
The primary outcome measure is effectiveness and will be evaluated as absence 
of pregnancy during LevoCept use. Pregnancies judged to have occurred while a 
study device was in place (determined by ultrasound and medical assessments) 
will be included in the analysis of pregnancies.  
 
For the primary evaluation of effectiveness, the Pearl index (and 95% confidence 
intervals) will be calculated in subjects aged 18-35 at the time of LevoCept 
placement through the date of LevoCept removal or pregnancy, excluding the 
following (unless the subject became pregnant in the cycle): 
• Cycles where back-up contraception use was reported by the patient  
• Cycles with no intercourse.   
• Cycles in which emergency contraception was used 
The Pearl Index is based on 28-day cycles and defined as the number of 
pregnancies per 100 woman-years (with one year comprising 13 28-day cycles). 
The cycle is defined as 28 days with the day of LevoCept placement as cycle 1 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 43 of 47 
day 1. Pearl index will be summarized annually for each of the 3 years and 
cumulatively. 
 
The EP population will be used for the primary evaluation of effectiveness. 
Life table (Kaplan-Meier method) analyses will be used as further assessment of 
pregnancies. Pregnancy rate will also be summarized annually for each of the 3 
years and cumulatively. 
20.7 
Safety and Other Outcome Measures 
All safety and other outcome measures will be analyzed using the ITT/Safety 
Population unless noted otherwise. Confidence intervals will be provided to 
support interpretation of the observed safety rates. 
 
LevoCept Characteristics 
Study device ease of placement and placement success will be summarized. 
Cumulative study device expulsion rates will be summarized  
 
Adverse Events 
The number and percentage of subjects with each adverse event and serious 
adverse event will be presented in a table by MedDRA system-organ class and 
preferred term.  Summaries will also be presented by relationship to the 
LevoCept placement or removal procedure and the severity of the adverse event.   
All adverse events will be summarized with special attention to those events that 
may be related to an intrauterine contraceptive, including: 
• 
Acne 
• 
Amenorrhea 
• 
Back pain 
• 
Breast cancer 
• 
Breast tenderness 
• 
Depression/depressive mood  
• 
Dysmenorrhea 
• 
Dyspareunia 
• 
Ectopic pregnancy  
• 
Embedment 
• 
Expulsion, partial or complete 
• 
Headache, migraine 
• 
Intrauterine pregnancy 
• 
Irregular menstrual bleeding 
• 
Leukorrhea 
• 
Ovarian cysts 
• 
Pain and cramping 
• 
Pelvic infection  
• 
Perforation 
• 
Sepsis 
• 
Vaginitis 
• 
Vasovagal reaction immediately after placement 
 
LevoCept Safety-Related Removal Rates and Expulsion Rates 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 44 of 47 
Cumulative LevoCept safety-related removal rates and expulsion rates at each 
year will be summarized. 
 
Bleeding and Spotting Patterns 
Vaginal bleeding and spotting will be recorded daily by the subject in her e-diary. 
The ITT and ECYC populations will be used for the bleeding and spotting 
summaries. The number of bleeding or spotting days will be summarized for 
each cycle. In addition, bleeding and spotting will be summarized separately. 
Subjects who discontinue the study due to bleeding complaints prior to 
completing one 28-day cycle will be included in the bleeding analysis. 
 
Occurrence and Severity of Dyspareunia 
Pain with intercourse will be recorded daily by the subject in her e-diary. The 
occurrence and severity of dyspareunia will be summarized for each cycle in 
ECYC population. 
 
Other Safety Assessments 
Changes in vital signs from baseline to each visit will be summarized for the 
physical examination and vital sign results. 
 
20.8 
Monitoring of Safety and Pregnancy 
Periodic reviews of safety and pregnancy rates will be conducted by a Medical 
Monitor.  New findings of safety concerns or pregnancies will be communicated 
to all study sites.  A Clinical Events Committee (CEC) will be assembled to 
review study data if >1 pregnancy is reported. 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 45 of 47 
APPENDIX 1. 
INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for ensuring that the clinical study is conducted 
according to the Investigator Agreement, Clinical Investigational Plan (CIP), all 
conditions of national regulatory requirements, the governing IRB, and in accordance 
with the highest standards of medical and ICH E6 Good Clinical Practice (GCP), and 
the Declaration of Helsinki. 
 
The Investigator(s) shall be responsible for the day-to-day conduct of the 
investigation as well as for the safety and well-being of the human subjects involved 
in the clinical investigation.  The Investigator(s) shall: 
 
a) Have the resources to conduct the investigation properly 
b) Ensure that conducting the investigation will not give rise to a conflict of 
interest 
c) Obtain from the Sponsor the information which the Investigator(s) judges 
essential about the study device and be familiar with this information 
d) Be well acquainted with the protocol before signing it 
e) Support the monitor and/or auditor, if applicable, in their activities to verify 
compliance with the protocol, to perform source data verification and to 
correct the eCRFs where inconsistencies or missing values are identified 
f) Discuss with the Sponsor management any question or modification of the 
protocol 
g) Make sure that the protocol is followed by all responsible for the conduct of 
the study at his/her institution.  Any deviation shall be documented and 
reported to the study Sponsor. 
h) Make the necessary arrangements to ensure the proper conduct and 
completion of the investigation 
i) Make the necessary arrangements for emergency treatment, as needed, to 
protect the health and welfare of the subject 
j) Ensure that appropriate IRB approvals are obtained prior to the start of the 
investigation 
k) Provide the communication from the IRB to the study sponsor 
l) Inform the IRB about any serious adverse device effects in accordance with 
the IRB requirements. 
m) Inform the Sponsor about any adverse events and adverse device effects in 
a timely manner and in accordance with the timelines laid out in this 
protocol 
n) Endeavor to ensure an adequate recruitment of subjects 
o) Ensure that the subject has adequate time and information to give informed 
consent 
p) Ensure that informed consent authorization to release protected health 
information is obtained and documented prior to any study specific 
evaluations or procedures being performed 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 46 of 47 
q) Ensure that clinical records are clearly marked to indicate that the subject is 
enrolled in this study 
r) Provide subjects with well-defined procedures for any emergency situation 
and safeguard the subject’s interest 
s) Ensure that information which becomes available as a result of the clinical 
investigation which may be of importance to the health of a subject and the 
continuation of the investigation shall be made known to: 1) the Sponsor; 2) 
the subject; and 3) the subject’s personal clinician (with the subject’s 
approval), if pertinent to the safety or well-being of the subject 
t) Inform the subject and/or the subject’s physician (with the subject’s 
approval) about any premature termination or suspension of the 
investigation with a rationale for study termination 
u) Have primary responsibility for the accuracy, legibility and security of all 
investigational data, documents and subject records both during and after 
the investigation 
v) Review and sign each subject’s eCRFs (last page only) 
w) Be responsible for the supervision and assignment of duties at his/her study 
center 
x) Ensure that all investigational devices are accounted for (number of devices 
used, discarded and returned to the Sponsor) 
y) Disclose to the Sponsor sufficient accurate financial information to allow the 
Investigator to submit complete and accurate certification or disclosure 
statements, and update the information during the course of the 
investigation and for one year following the completion of the study 
z) Ensure that the Investigator discloses to the Sponsor if the Investigator has 
ever been associated with terminated research and the reason for such 
termination is provided 
aa) Ensure that the Investigator discloses to the Sponsor if the Investigator has 
ever been barred from conducting or participating in clinical research. 
 
 
 

ContraMed, LLC LevoCept  
Phase 2 Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0022 Version 4.0 / 18 Oct 2017 
Confidential  
 
 
Page 47 of 47 
 
 
 
 
 
End of document -