POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN
Conditions: Product Surveillance, Postmarketing
Sponsor: Pfizer

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Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 2 of 32 
TABLE OF CONTENTS 
1. LIST OF ABBREVIATIONS ................................................................................................4 
2. RESPONSIBLE PARTIES ....................................................................................................5 
3. AMENDMENTS AND UPDATES .......................................................................................6 
4. MILESTONES .......................................................................................................................9 
5. RATIONALE AND BACKGROUND ..................................................................................9 
6. RESEARCH QUESTION AND OBJECTIVES .................................................................10 
7. RESEARCH METHODS ....................................................................................................11 
7.1. Study design ............................................................................................................11 
7.1.1. Safety Endpoints .........................................................................................11 
7.1.2. Effectiveness Endpoints..............................................................................11 
7.2. Setting ......................................................................................................................11 
7.2.1. Inclusion criteria .........................................................................................12 
7.2.2. Exclusion criteria ........................................................................................12 
7.3. Variables ..................................................................................................................12 
7.3.1. Data Collection ...........................................................................................13 
7.4. Data sources ............................................................................................................15 
7.5. Study size ................................................................................................................15 
7.6. Data management ....................................................................................................15 
7.7. Data analysis ...........................................................................................................19 
7.7.1. Assessment of Safety and Effectiveness Parameters ..................................19 
7.7.2. Statistical Considerations ............................................................................19 
7.8. Quality control .........................................................................................................20 
7.8.1. Record retention ..........................................................................................20 
7.9. Limitations of the research methods .......................................................................21 
7.10. Other aspects .........................................................................................................21 
8. PROTECTION OF HUMAN SUBJECTS ..........................................................................21 
8.1. Patient Information and Consent .............................................................................21 
8.2. Patient withdrawal ...................................................................................................21 
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............22 
8.4. Ethical Conduct of the Study ..................................................................................22 
9. ADVERSE EVENT REPORTING......................................................................................22 
9.1. Requirements ...........................................................................................................22 
9.1.1. Reporting period .........................................................................................23 

Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 3 of 32 
9.1.2. Causality assessment ..................................................................................23 
9.2. Definitions of Safety Events ...................................................................................24 
9.2.1. Adverse events ............................................................................................24 
9.2.2. Serious adverse events ................................................................................25 
9.2.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours ...........26 
9.2.4. Medical Device Complaint Reporting Requirements .................................29 
9.2.5. Communication of Issues ...........................................................................29 
9.3. Single reference safety document............................................................................29 
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY 
RESULTS ...........................................................................................................................30 
11. REFERENCES ..................................................................................................................31 
12. LIST OF TABLES .............................................................................................................31 
13. LIST OF FIGURES ...........................................................................................................31 
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS .........................................................32 
ANNEX 2. ADDITIONAL INFORMATION .........................................................................32 
 
 
 
 
 
 

Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 4 of 32 
1. LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
SAE 
Serious Adverse Event 
CRF 
Case Report Form 
eCRF 
Electronic Case Report Form 
CDC 
Clinical Data Coordinator 
DC 
Data Coordinator 
DCF 
Data Clarification Form 
DMPA 
Depot Medroxyprogesterone Acetate 
DVP 
Data Validation Plan 
EIU 
Exposure in Utero 
IRB/IEC 
Institutional Review Board/Independent Ethics 
Committee 
LSLV 
Last Subject Last Visit 
MFDS 
Ministry of Food and Drug Safety 
NA 
Not Applicable 
ODC 
Obvious Data Correction 
PV 
Pharmacovigilance 
SAP 
Statistical Analysis Plan 
 
 
 

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Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 7 of 32 
Document  
Version 
Date 
Substantial 
amendment or  
Administrative 
amendment 
Summary of Changes 
has been clarified. 
3. Section 8.7.1.2. Safety Parameters: 
Additional instruction was added. 
Amendment due to SOP requirement: 
1. Section 10.1.3. DEFINITION OF AN 
ADVERSE EVENT: The detail to report 
overdose, misuse, extravasation associated 
with the use of a Pfizer product has been 
added. 
2. Section 11.  PLANS FOR 
DISSEMINATING AND 
COMMUNICATING STUDY 
RESULTS: It has been amended per SOP. 
3. Section 10.1.1.5: Lack of efficacy 
reporting requirement was changed. 
Others: 
1. Section 5. MILESTONE: Typo correction. 
2. Section 8.2. Setting: Correction per local 
regulation 
3. Section 8.3.1.1. General Information: 
“Initial of subject”, which would not be 
collected, has been deleted. 
4. Section 8.3.1.4. Concomitant Medication/ 
Therapy: Typo correction. 
5. Section 8.3.1.5 Administrative Status for 
Sayana®: CRF change was applied. 
Amendment 3 
26 Mar 
2015 
Substantial 
Amended per SOP;  
1. Section 10. Averse Event Reporting: 
Amended with Safety Reporting Language 
(effective date: 31 Dec 2013) SOP Update.  
Amendment  4 
08 Jul 
2016 
Substantial 
Amended the total target enrollment number in 
accordance with MFDS Appeal Letter. 
Terms revision; Korean term of “Adverse 
Event” is changed in accordance with 
updated MFDS Re-Examination 
Guideline.  
Others: 
1. “Table of Contents” number correction.  
Amendment 5 
24 Aug 
2016 
Substantial 
Amended the total target enrollment number to 
submit the complemented document for 
Appeal letter to MFDS. 
Amendment 6 
21 Feb 
2017 
Substantial 
1. Section 5. RATIONALE AND 
BACKGROUND & Section 7.5. Study size: 
Amended  target enrollment number to 
initial number 

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Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 9 of 32 
4. MILESTONES 
Milestone 
Planned date 
Start of data collection  
01 April 2014 
End of data collection  
28 January 2019 
Interim report 1 -1 
29 July 2013~28 September 2013 
Interim report 1-2 
29 January 2014~28 March 2014 
Interim report 2-1 
29 July 2014~28 September 2014 
Interim report 2-2 
29 January 2015~28 March 2015 
Interim report 3 
29 January 2016~28 March 2016 
Interim report 4 
29 January 2017~28 March 2017 
Interim report 5 
29 January 2018~28 March 2018 
Re-Examination application report 
29 January 2019~28 April 2019 
Interim report 7 
29 January 2020~28 March 2020 
Final Study Report (8) 
29 January 2021~28 April 2021 
Product Market Launching 
01 July 2013 
 
5. RATIONALE AND BACKGROUND 
In light of the number of unplanned pregnancies, women recognize the need for 
contraception and family planning.1,2,3  In addition to controlling the size of their families, 
couples also want to control the timing and spacing of births.  Moreover, the job of family 
planning will never be finished.  With each new generation, comes a new set of 
parameters affecting use of contraception. 
Barriers to using contraception include worries about side effects, health concerns, social 
disapproval or partner’s opposition, financial limitations and lack physical access.  In 
addition, lack of information about nondaily hormonal contraceptives may also be a 
barrier for women considering contraception.  The success of many family planning 
programs has been linked to removing administrative and medical barriers.  Nondaily 
contraceptives can increase compliance.  With oral contraceptives, missed pills are 
common and contribute to unintended pregnancies.4  Nondaily contraceptives offer 
dosing options that reduce the likelihood of missed dose.5 
Sayana®, revised formulation of depot medroxyprogesterone acetate (DMPA), is 
specifically formulated for subcutaneous administration. The contraceptive efficacy of 
Sayana®has been demonstrated in 2 large, multinational contraceptive trials, in which 

Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 10 of 32 
Sayana® was highly effective and generally well tolerated.  Zero pregnancies were 
reported in both trials (N=1,787) under perfect use conditions.6  
In addition to its high efficacy, Sayana® delivers a lower dose of medroxyprogesterone 
acetate than Depo-Provera Contraceptive Injection 150 mg/mL (medroxyprogesterone 
acetate injectable suspension, 150 mg/mL) and offers subcutaneous administration once 
every 3 months, thereby eliminating the need for the discipline of daily dosing.6  
Sayana® benefits from the established clinical history of Depo-Provera CI 150 mg for 
intramuscular administration, which contains the same active ingredient in a different 
formulation.  Depo-Provera CI 150 mg has been available worldwide for decades and in 
the United States since 1992. Over 68 million women in over 114 countries worldwide 
have used Depo-Provera CI 150 mg, and the years of experience with Depo-Provera CI 
150 mg worldwide provide a large body of long-term data regarding its safety and 
efficacy.7,8  
In December 2004, the FDA approved Sayana® for use as a contraception. Sayana® was 
approved in 48 countries over the world, among which 33 countries marketed Sayana® 
while 15 countries are under preparation for marketing. 
Women who use Sayana® may lose significant bone mineral density. Bone loss is greater 
with increasing duration of use and may not be completely reversible. It is unknown if use 
of Sayana® during adolescence or early adulthood, a critical period of bone accretion, will 
reduce peak bone mass and increase the risk for osteoporotic fracture in later life. 
Sayana® should be used long-term (eg, longer than 2 years) only if other methods of birth 
control are inadequate.9 
In South Korea, Sayana® was first approved as new medicine on 29 Jan 2013 by Ministry 
of Food and Drug Safety (MFDS).  As required for any new medication approved by 
MFDS of Korea, Republic of, safety and effectiveness information of new medication 
should be provided at minimum 600 subjects administered in the setting of routine 
practice during the initial 6 years after the approval (29 Jan 2013 ~ 28 Jan 2019) through 
Post-Marketing Surveillance study. 
However, as of 05 Mar 2018, MFDS approved 2 more years re-examination period 
extension due to low sales trend and enrollment difficulty after marketing. This study will 
be conducting by 28 Jan 2021 then safety and effectiveness information will be provided 
from these minimum 600 subjects. 
 
6. RESEARCH QUESTION AND OBJECTIVES 
This study is to describe the safety and effectiveness of Sayana® during the usual care 
setting. 
The objective can be specified as below: 
 To detect serious adverse events and adverse drug reactions.  
 To detect unexpected adverse events and adverse drug reactions that are not 
included in precaution of local product document.  

Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 11 of 32 
 To observe already known adverse drug reactions.  
 To observe non-serious adverse drug reactions. 
 To detect other information on safety and effectiveness. 
7. RESEARCH METHODS  
7.1. Study design  
This study is an open-label, non-comparative, observational, non-interventional, 
prospective and multi-center study in which subjects administered Sayana® (administered 
as part of routine practice in Korean health care centers by accredited physicians) will be 
observed prospectively for a period of 6 months from the enrollment date.  The visit 
schedule or interval will be decided by the investigator. 
7.1.1. Safety Endpoints 
 Incidence of adverse events categorized according to physical organ and 
disease/symptom. 
7.1.2. Effectiveness Endpoints 
 Cumulative percent of patients who become pregnant over the 6 month 
observation period and rate of pregnancies per 100 person-years of follow-up. 
 The patient response to endometriosis pain treatment: endometriosis pain 
treatment effect will be measured by visual analogue scale scores recorded by the 
subjects at each visit.  The subject will be asked to indicate the subjective level of 
endometriosis pain looking back at the last 3 months and mark it with a single 
vertical mark on the 100mm horizontal visual analogue scale, where 0 mm 
represents absence of pain and 100mm indicates unbearable pain.  
7.2. Setting 
Subjects will be enrolled by continuous registration method.  The investigators will assess 
all the subjects in their practice who receive at least 1 dose of Sayana® 104mg/0.65mL 
agreed to participate in this study by signing the ‘data privacy statement’.  All subjects 
enrolled should meet the usual prescribing criteria for as Sayana® per the local product 
document and should be entered into the study at the investigator’s discretion. 
A written, Pfizer and institutional review board (IRB)/independent ethics committee 
(IEC)-approved, informed consent (ie, Data privacy statement) must be obtained before 
initiating study procedures. 
The eligibility of the subject will be evaluated. After inclusion of the subject and after 
obtaining written informed consent (ie, Data privacy statement) (prior to any procedure 
being performed) from the subject or subject’s parents/ legal representative (as 
appropriate), the investigator or site staff will record the subject data into source 
documents and into a Case Report Form (CRF).  Enrollment visit is the visit when subject 
signs on informed consent (ie, Data privacy statement).  Following the baseline data 
collection , the visits are at the discretion of the investigator and may follow the local 
usual standard of care, however, the sponsor recommends safety and treatment data 

Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 12 of 32 
assessments at 3 month intervals (every 12~14weeks) at a minimum during the 6 months 
of participation.  A Follow-up Call is to be conducted by investigator or delegated staffs 
at least 28 calendar days after the last administration of the study drug within the 
observational period in order to collect information on the occurrence of adverse events 
and concomitant medications. 
7.2.1. Inclusion criteria 
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the 
study: 
1. Subjects or legally authorized representatives of pediatric subjects agree to 
provide written informed consent form (ie, data privacy statement). 
Women subjects who are initiating treatment with Sayana® for the first time as per the 
local product document for usage Evidence of a personally signed and dated informed 
consent document indicating that the patient (or a legally acceptable representative) has 
been informed of all pertinent aspects of the study is required. 
7.2.2. Exclusion criteria 
Patients meeting any of the following criteria will not be included in the study: 
1. Known or suspected pregnancy.  
2. Undiagnosed vaginal bleeding.  
3. Known or suspected malignancy of breast.  
4. Active thrombophlebitis, or current or past history of thromboembolic disorders, 
or cerebral vascular disease.  
5. Significant liver disease.  
6. Known hypersensitivity to medroxyprogesterone acetate or any of its other 
ingredients.  
7. Women who are before menarche or who are post-menopausal. 
8. Treatment with any investigational agent or device within 30 days prior to the 
enrollment visit. 
7.3. Variables 
Variable 
Role 
Data source(s) 
Operational 
definition 
Demographic Characteristics 
Baseline 
characteristics 
Medical records 
* 
Basic Laboratory data 
Baseline 
characteristics 
Laboratory test 
results 
* 
Concomitant medication 
Baseline 
characteristics 
Medical records 
* 

Medroxyprogesterone acetate (Sayana®) 
A6791036 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 8, 21Mar2018  
 
 
Pfizer Confidential 
Page 13 of 32 
Variable 
Role 
Data source(s) 
Operational 
definition 
Effectiveness result by 
investigator 
Outcome 
Medical records 
* 
Adverse Event (AE) 
Outcome 
Medical records 
* 
* Refer to Section 7.3.1 data collection  
Detail instruction of variable will be included in the CRF. 
7.3.1. Data Collection 
The investigator will observe each enrolled subject for 6 months, prospectively, from the 
enrollment date. There is no specified visit schedule, because this study is not an 
interventional study.  Safety information will be collected at every visit performed for the 
subject during the observation period.  
7.3.1.1. General Information 
 Name of Institution: Record the name of the institution. 
 Name of Investigator: Record the name of the physician contracted to conduct the 
study. 
 Department: Record the medical department conducting the study. 
 Subject ID: Record 4 digit number per subject registration sequence. 
 Confirmation of Data Privacy Statement:  If all agreement for using subject’s 
personal and medical information, signature and date are obtained by subject or 
legally authorized representative, then check the box of ‘yes’. If not, check ‘no’ 
which means that case is excluded from this study. 
 Date of contract: Record the date of contract between the Investigator/Institution 
and the Sponsor. 
7.3.1.2. Demographic Information 
 Age: Record the age of the subject. 
 Sex: Check ‘female’. 
 Pregnancy: Check the box next to ‘yes’ or ‘no’ and record the method of 
pregnancy test. 
 Weight: Record by kg unit. 
 Height: Record by cm unit. 
 Purpose of administration: Check either the prevention of pregnancy in women of 
child bearing potential or management of endometriosis-associated pain. 
 VAS at Baseline: If the purpose of administration was management of 
endometriosis-associated pain, visual analogue scale scores recorded by the subject. 

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7.3.1.3. Medical History 
Select either ‘yes’ or ‘no’ for past/present disease. If ‘yes’ then write adequate full name 
of the disease down as Medical Terminology Dictionary indicates (written by Korean 
Medical Association) and select either ‘past’ or ‘present’ at each disease clause. 
7.3.1.4. Concomitant Medication/Therapy  
The investigator records the medication/therapy which has been administered/conducted 
continuously at the point of being enrolled in this study or administered/conducted newly 
after being enrolled.  Check either ‘yes’ or ‘no’. If ‘yes’, record in detail. 
 Name of drug/Therapy name: Record generic name in case of single product and 
record trade name in case of combination product. Also, record name of 
concomitant therapy. 
 Daily total dosage/Frequency: Record the daily total dosage as unit.  If not 
combination drug, avoid recording in tablets, capsules or vials.  Record the 
frequency of concomitant therapy. 
 Duration of administration/Duration of therapy: Record the starting/ending date of 
the medicated drug and concomitant therapy (year/month/day).  If the medication 
and therapy are being continued at the completion of the study, record the starting 
date date and check in the box next to ‘Ongoing’. 
 Purpose of administration/Purpose for therapy: Record the purpose of 
administration or therapy. 
7.3.1.5. Administrative Status for Sayana® 
Sayana® is provided by the investigator’s prescription, and Pfizer Korea will not provide 
Sayana® for this study. 
Record the following with regard to administrative status of Sayana®. 
 Date of administration: Record the date of each Sayana® therapy (year/ month/day. 
 Dose: Record the dose (ml).  
 Outcome of administration:  
Record the evaluation date. If the purpose of administration was the prevention of 
pregnancy in women of child bearing potential, check either pregnant or not 
pregnant with the method of pregnancy check.  If the subject is pregnant, record 
the first day of last menstrual period to collect the time to pregnancy.  (At the time 
of first Sayana® administration, investigator must ensure the subject is non-
pregnant.  Also if a sexually active subject is having regular menstrual cycle and 
was previously not being administered with other contraceptive agent (therefore is 
having normal menstrual cycle), investigator must ensure that the first Sayana® 
injection is within 5 days of the subject’s normal menstrual cycle.  If the subject 
was previously being administered with other contraceptive agent(s) and is not 
having normal menstrual cycle, investigator must ensure that the subject is not 
pregnant by a method decided by the investigator). 

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If the purpose of administration was management of endometriosis-associated pain, 
visual analogue scale scores recorded by the subject.  
7.3.1.6. Safety  
7.3.1.6.1. Adverse Event  
Refer to Section 9 of this protocol and Case Report Form blank form. 
7.3.1.6.2. Laboratory Test 
Laboratory test is not mandatory because this study is a non-interventional study.  If 
investigator performed a laboratory test (eg, Serum HCG, CBC, Chemistry and Urine) 
under their usual practice, the results can be collected.  Check ‘not done’ if it is not 
performed.  If ‘done’, record the following in detail. 
 Name of laboratory test: Record the item of laboratory test. 
 Normal range (unit): Record the normal range and its unit for each recorded item 
in each institution. 
 Date for laboratory test: Record the date with year / month / day. 
 Test result before / after medication: Record the test result. 
Refer to [Section Error! Reference source not found..] of the criteria for determining 
whether an abnormal objective test finding should be reported as an adverse event. If it 
meets the criteria, it has to be recorded in the adverse event section of the case report 
form. 
7.4. Data sources  
The followings are data sources for the study: 
1. Medical and nurse records; 
2. Laboratory test results. 
7.5. Study size 
More than 600 subjects should be observed per “Basic Standards for the Re-examination 
of New Medicines” (Korea MFDS notification No. 2016-97, 2016.9.6., Amendment) 
7.6. Data management  
As used in this protocol, the term CRF should be understood to refer to either a paper 
form or an electronic data record or both, depending on the data collection method used in 
this study (“eCRF” may be used to describe an electronic data record).  
A CRF should be completed for each included subject.  The completed original CRFs are 
the sole property of Pfizer and should not be made available in any form to third parties, 
except for authorized representatives of Pfizer or appropriate regulatory authorities, 
without written permission from Pfizer. 
Each study investigator has ultimate responsibility for the collection and reporting of all 
clinical, safety and laboratory data entered on the CRFs and any other data collection 

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forms (source documents) and ensuring that they are accurate, authentic / original, 
attributable, complete, consistent, legible, timely (contemporaneous), enduring and 
available when required.  The CRFs must be signed by the study investigator or by an 
authorized staff member to attest that the data contained in the CRFs are correctly 
recorded.  Any corrections to entries made in the CRFs, source documents must be dated, 
initialed and explained (if necessary) and should not obscure the original entry.  For 
studies using electronic data capture systems, an audit trail of any corrections to original 
data entry must be ensured.  
In many cases, the source document is the subject medical chart.  In these cases, data 
collected on the CRFs must match the data in the chart.  
In some cases (eg, subject interview), the CRF, or part of the CRF, may also serve as 
source documents.  In these cases, a document should be available at the investigator’s 
site as well as at Pfizer and clearly identify those data that will be recorded in the CRF, 
and for which the CRF will stand as the source document. 

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Figure 1. Data Management Flow Chart 
 
 
Preparation & Planning 
 
 
 
 
 
 
 
CRF Receiving 
 
DB Designing 
 
DVP 
 
 
 
 
  
  
 
 
 
  
CRF Receipt Form 
 
DB Testing &  
Verification 
 
Validation Procedure 
writing 
 
 
 
 
 
 
 
 
 
 
 
 
 
DB Approval 
 
Validation Procedure 
Verification 
 
 
 
 
 
 
 
Entry /Comparison 
/Reconciliation 
 
 
 
 
 
 
 
 
 
 
 
 
Discrepancy Check 
 
 
 
 
Data Validation 
Incl. SAE Reconciliation 
 
 
 
 
DCF 
 
 
 
 
 
 
 
 
 
 
 
ODC 
 
DCF Resolution 
 
 
 
 
 
 
Data Correction 
 
 
 
 
 
 
 
 
Is there any unresolved 
DCF? 
 
 
 
 
 
 
 
No   
Yes 
 
 
Medical Coding 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
Data Quality Check 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Database Lock 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Transfer/Archive 
 
 
 
 
 
 
 
 
 

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Figure 2. Data Validation Flow Chart 
 
CRA 
DC 
DC 
DC 
Yes 
No 
DC 
Yes (9) 
 (9) 
No 
DC 
Obvious Data correction (4) 
Discrepancy Generation (1) 
Generate DCF (5) 
  CRA 
Data error checking (2) 
DC 
DC 
CRA 
CDC 
Medical review 
( )
Send Draft DCF to  
CRA 
Resolve DCF (8) 
 
Retrieve DCF from 
Investigators 
Data Correction 
(10) 
Is there any   
unresolved 
Review Draft DCF (6) 
 
Investigator 
Send DCF to  
CRA (11) 
Is it necessary that 
DCF is generated? 
Keep DCF with 
CRF (12) 
Data Fix (13) 
Send DCF to Site (7) 
 
CR

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7.7. Data analysis  
7.7.1. Assessment of Safety and Effectiveness Parameters 
7.7.1.1. Analysis Populations 
All analyses will be performed on the safety population, defined as those patients who 
took at least one dose of study medication. 
7.7.1.2. Safety Parameters 
Safety parameters include: 
 Adverse events and serious adverse events; 
 Premature discontinuations from the study due to adverse events; 
 Use of concomitant medications due to adverse events; 
 Clinically significant abnormalities from laboratory test. 
7.7.1.3. Effectiveness Parameters 
Effectiveness parameters include: 
 Cumulative percent of patients who become pregnant over the 6 month 
observation period. 
 Rate of the number of pregnancies per 100 per-years of follow-up. 
 Change from baseline in visual analogue scale (VAS) endometriosis pain scores at 
each visit. 
Figure 3. Visual Analogue Scale  
  
 
Source: Gerlinger C, Schumacher U, Wentzeck R, et al [10] 
7.7.2. Statistical Considerations 
Statistical analyses of safety and effectiveness parameters will be primarily descriptive in 
nature; no statistical hypotheses will be tested.  No imputations for missing data are 
planned. 
As required by MFDS regulations, the periodic report should be submitted to MFDS 
every 6 months for the first two years and then annual report should be submitted to 
MFDS for the third, fourth and fifth year.  The final report should be submitted in the 
sixth year.  Interim analysis will be performed in time for the report submission. 
7.7.2.1. Safety Analyses 
All safety parameters will be summarized in accordance with Pfizer Data Standards 
(PDS) for safety reporting.  Medical histories and patient demographics will also be 
summarized using PDS.  Selected and/or common adverse events will be further 
described using a 95% confidence interval for binomial proportions. 

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The dosage and number of injections of study medication will be summarized using 
descriptive statistics. 
7.7.2.2. Effectiveness Analyses 
 The cumulative percent of patients who become pregnant by month 6 will be 
calculated as 100*(1 – Kaplan-Meier curve at month 6), where the Kaplan-Meier 
(KM) method for estimating survival function will be applied to time-to-
pregnancy.  Patients who did not become pregnant will be censored at the time of 
their last follow-up.  The KM method will also be used to calculate a 95% 
confidence interval for this cumulative percent at month 6. 
 The rate of pregnancies per 100 person-years of follow-up will be accompanied by 
an 95% confidence interval; this confidence interval will be based on the Poisson 
distribution. 
 Mean change in VAS scores from baseline will be tested against zero change 
using the paired t-test; p-values ≤ 0.05 will indicate statistically significant 
change.  Mean change will also be described using a 95% confidence interval. 
Detailed methodology for summary and statistical a nalyses of data collected in this study 
will be documented in a SAP, which will be dated, filed and maintained by the sponsor.  
The SAP may modify the plans outlined in the protocol; any major modifications of 
primary endpoint definitions or their analyses would be reflected in a protocol 
amendment. 
7.8. Quality control 
Data Quality Measurement is performed by Data QC Coordinator to define the level of 
data quality and evaluate the data quality. 
For all items, 10% Data Quality Check is conducted before the DB lock.  If error rate is 
satisfied less than 0.05%, Data Quality Check is stopped, if not, 10% sampling and Data 
Quality Check is repeated.  In repeated Data Quality Check, if error rate is satisfied less 
than 0.05%, Data Quality Check is stopped, if not, 100% Data Quality Check is made.  
As a result of 10% sampling, only if more than 100 subjects is sampled, Data Quality 
Check is conducted for 100 subjects.  
CRF-to-Database Inspection outcomes will be approved by Pfizer Korea. 
7.8.1. Record retention 
To enable evaluations and/or audits from regulatory authorities or Pfizer, the investigator  
agrees to keep records, including the identity of all participating subjects (sufficient 
information to link records, eg, CRFs and hospital records), all original signed informed 
consent forms (ie, data privacy statement), copies of all CRFs, serious adverse event 
forms, source documents, and detailed records of treatment disposition, and adequate 
documentation of relevant correspondence (eg, letters, meeting minutes, telephone calls 
reports).  The records should be retained by the invesitgator according to local regulations, 
or as specified in the Clinical Study Agreement, whichever is longer. 

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If the investigator becomes unavailable for any reason to continue to retain study records 
for the required period (eg, retirement, relocation), Pfizer should be prospectively notified.  
The study records must be transferred to a designee acceptable to Pfizer, such as another 
investigator, another institution, or to an independent third party arranged by Pfizer.  The 
investigator must obtain Pfizer's written permission before disposing of any records, even 
if retention requirements have been met. 
7.9. Limitations of the research methods 
 Regulatory- required study for maintaining license and exclusivity. 
 SAP and number of enrolled subjects are ruled by PMS guideline of Korea MFDS, 
not specific to disease and/or drug characteristics.  
7.10. Other aspects 
Not applicable. 
 
8. PROTECTION OF HUMAN SUBJECTS 
8.1. Patient Information and Consent 
All parties will ensure protection of patient personal data and will not include patient 
names on any sponsor forms, reports, publications, or in any other disclosures, except 
where required by laws.  In case of data transfer, Pfizer will maintain high standards of 
confidentiality and protection of patient personal data. 
The informed consent form must be in compliance with local regulatory requirements and 
legal requirements. 
The informed consent form used in this study, and any changes made during the course of 
the study, must be prospectively approved by both the IRB/IEC and Pfizer before use. 
The investigator must ensure that each study patient, or his/her legally acceptable 
representative, is fully informed about the nature and objectives of the study and possible 
risks associated with participation.  The investigator, or a person designated by the 
investigator, will obtain written informed consent from each patient or the patient’s 
legally acceptable representative before any study-specific activity is performed.  The 
investigator will retain the original of each patient's signed consent form. 
8.2. Patient withdrawal 
Patients may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, or administrative reasons.  In any circumstance, every effort should be made 
to document subject outcome, if possible.  The investigator should inquire about the 
reason for withdrawal and follow-up with the subject regarding any unresolved adverse 
events.   
If the patient withdraws from the study, and also withdraws consent for disclosure of 
future information, no further evaluations should be performed, and no additional data 

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should be collected.  The sponsor may retain and continue to use any data collected 
before such withdrawal of consent. 
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the study 
protocol, protocol amendments, and informed consent forms, and other relevant 
documents, (eg, recruitment advertisements), if applicable, from the IRB/IEC.  All 
correspondence with the IRB/IEC should be retained in the Investigator File.  Copies of 
IRB/IEC approvals should be forwarded to Pfizer.  
8.4. Ethical Conduct of the Study 
The study will be conducted in accordance with legal and regulatory requirements, as 
well as with scientific purpose, value and rigor and follow generally accepted research 
practices described in Good Pharmacoepidemiology Practices (GPP) issued by the 
International Society for Pharmacoepidemiology (ISPE), Good Epidemiological Practice 
(GEP) guidelines issued by the International Epidemiological Association (IEA). 
 
9. ADVERSE EVENT REPORTING 
9.1. Requirements 
The table below summarizes the requirements for recording safety events on the case 
report form and for reporting safety events on the non-interventional study (NIS) adverse 
event monitoring (AEM) Report Form to Pfizer Safety.  These requirements are 
delineated for three types of events: (1) serious adverse events (SAEs); (2) non-serious 
AEs (as applicable); and (3) scenarios involving drug exposure, including exposure 
during pregnancy, exposure during breast feeding, medication error, overdose, misuse, 
extravasation, and occupational exposure.  These events are defined in the section 
“Definitions of safety events”.   
 
Safety event 
Recorded on the case report 
form  
Reported on the NIS AEM 
Report Form to Pfizer 
Safety within 24 hours of 
awareness 
SAE 
All 
All 
Non-serious AE 
All 
None 
Scenarios involving exposure 
to a drug under study, 
including exposure during 
pregnancy, exposure during 
breast feeding, medication 
error, overdose, misuse, 
extravasation; lack of efficacy; 
and occupational exposure 
All (regardless of whether 
associated with an AE), 
except occupational 
exposure  
All (regardless of whether 
associated with an AE) 
 

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For each AE, the investigator must pursue and obtain information adequate both to 
determine the outcome of the adverse event and to assess whether it meets the criteria for 
classification as a SAE (see section "Serious Adverse Events” below).  
Safety events listed in the table above must be reported to Pfizer within 24 hours of 
awareness of the event by the investigator regardless of whether the event is 
determined by the investigator to be related to a drug under study. In particular, if 
the SAE is fatal or life-threatening, notification to Pfizer must be made immediately, 
irrespective of the extent of available event information. This timeframe also applies to 
additional new (follow-up) information on previously forwarded safety event reports. In 
the rare situation that the investigator does not become immediately aware of the 
occurrence of a safety event, the investigator must report the event within 24 hours after 
learning of it and document the time of his/her first awareness of the events. 
For safety events that are considered serious or that are identified in the far right column 
of the table above that are reportable to Pfizer within 24 hours of awareness, the 
investigator is obligated to pursue and to provide any additional information to Pfizer in 
accordance with this 24-hour timeframe. In addition, an investigator may be requested by 
Pfizer to obtain specific follow-up information in an expedited fashion.  This information 
is more detailed than that recorded on the case report form. In general, this will include a 
description of the adverse event in sufficient detail to allow for a complete medical 
assessment of the case and independent determination of possible causality.  Any 
information relevant to the event, such as concomitant medications and illnesses must be 
provided.  In the case of a patient death, a summary of available autopsy findings must be 
submitted as soon as possible to Pfizer or its designated representative.  
9.1.1. Reporting period  
For each patient, the safety event reporting period begins at the time of  the patient’s first 
dose of Sayana® or the time of the patient’s informed consent if s/he is already exposed to 
Sayana®, and lasts through the end of the observation period of the study, which must 
include at least 28 calendar days following the last administration of a drug under study; a 
report must be submitted to Pfizer Safety (or its designated representative) for any of the 
types of safety events listed in the table above occurring during this period.  If a patient 
was administered a drug under study on the last day of the observation period, then the 
reporting period should be extended for 28 calendar days following the end of 
observation. Most often, the date of informed consent is the same as the date of 
enrollment. In some situations, there may be a lag between the dates of informed consent 
and enrollment.  In these instances, if a patient provides informed consent but is never 
enrolled in the study (e.g., patient changes his/her mind about participation), the reporting 
period ends on the date of the decision to not enroll the patient.   
If the investigator becomes aware of a SAE occurring at any time after completion of the 
study and s/he considers the SAE to be related to Sayana®, the SAE also must be reported 
to Pfizer Safety.  
9.1.2. Causality assessment 
The investigator is required to assess and record the causal relationship.  For all AEs, 
sufficient information should be obtained by the investigator to determine the causality of 
each adverse event.  For AEs with a causal relationship to Sayana®, follow-up by the 

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investigator is required until the event and/or its sequelae resolve or stabilize at a level 
acceptable to the investigator, and Pfizer concurs with that assessment.   
An investigator’s causality assessment is the determination of whether there exists a 
reasonable possibility that Sayana® caused or contributed to an adverse event. If the 
investigator’s final determination of causality is “unknown” and s/he cannot determine 
whether Sayana® caused the event, the safety event must be reported within 24 hours.   
If the investigator cannot determine the etiology of the event but s/he determines that 
Sayana® did not cause the event, this should be clearly documented on the case report 
form and the NIS AEM Report Form.  
9.2. Definitions of Safety Events 
9.2.1. Adverse events 
An AE is any untoward medical occurrence in a patient administered a medicinal product.  
The event need not necessarily have a causal relationship with the product treatment or 
usage. Examples of adverse events include but are not limited to:   
 Abnormal test findings (see below for circumstances in which an abnormal test 
finding constitutes an adverse event); 
 Clinically significant symptoms and signs; 
 Changes in physical examination findings; 
 Hypersensitivity; 
 Progression/worsening of underlying disease; 
 Lack of efficacy;  
 Drug abuse;  
 Drug dependency. 
Additionally, for medicinal products, they may include the signs or symptoms resulting 
from: 
 Drug overdose; 
 Drug withdrawal; 
 Drug misuse;  
 Off-label use;  
 Drug interactions; 
 Extravasation; 

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 Exposure during pregnancy; 
 Exposure during breast feeding; 
 Medication error; 
 Occupational exposure. 
Abnormal test findings 
The criteria for determining whether an abnormal objective test finding should be 
reported as an adverse event are as follows:  
 Test result is associated with accompanying symptoms, and/or 
 Test result requires additional diagnostic testing or medical/surgical intervention, 
and/or 
 Test result leads to a change in study dosing or discontinuation from the study, 
significant additional concomitant drug treatment, or other therapy, and/or 
 Test result is considered to be an adverse event by the investigator or sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does 
not constitute an adverse event.  Any abnormal test result that is determined to be an error 
does not require reporting as an adverse event. 
9.2.2. Serious adverse events 
A serious adverse event is any untoward medical occurrence in a patient administered a 
medicinal or nutritional product (including pediatric formulas) at any dose that: 
 Results in death; 
 Is life-threatening; 
 Requires inpatient hospitalization or prolongation of hospitalization (see below for 
circumstances that do not constitute adverse events); 
 Results in persistent or significant disability/incapacity (substantial disruption of 
the ability to conduct normal life functions); 
 Results in congenital anomaly/birth defect. 
Medical and scientific judgment is exercised in determining whether an event is an 
important medical event.  An important medical event may not be immediately life-
threatening and/or result in death or hospitalization.  However, if it is determined that the 
event may jeopardize the patient or may require intervention to prevent one of the other 
outcomes listed in the definition above, the important medical event should be reported as 
serious. 

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Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization; or development of drug dependency or drug abuse. 
Additionally, any suspected transmission via a Pfizer product of an infectious agent, 
pathogenic or non-pathogenic, is considered serious.  The event may be suspected from 
clinical symptoms or laboratory findings indicating an infection in a patient exposed to a 
Pfizer product.  The terms “suspected transmission” and “transmission” are considered 
synonymous.  These cases are considered unexpected and handled as serious expedited 
cases by PV personnel.  Such cases are also considered for reporting as product defects, if 
appropriate. 
Hospitalization 
Hospitalization is defined as any initial admission (even if less than 24 hours) to a 
hospital or equivalent healthcare facility or any prolongation to an existing admission.  
Admission also includes transfer within the hospital to an acute/intensive care unit (e.g., 
from the psychiatric wing to a medical floor, medical floor to a coronary care unit, 
neurological floor to a tuberculosis unit). An emergency room visit does not necessarily 
constitute a hospitalization; however, an event leading to an emergency room visit should 
be assessed for medical importance.  
Hospitalization in the absence of a medical AE is not in itself an AE and is not reportable. 
For example, the following reports of hospitalization without a medical AE are not to be 
reported.  
 
Social admission (e.g., patient has no place to sleep) 
 
Administrative admission (e.g., for yearly exam) 
 
Optional admission not associated with a precipitating medical AE (e.g., 
for elective cosmetic surgery) 
 
Hospitalization for observation without a medical AE 
 
Admission for treatment of a pre-existing condition not associated with the 
development of a new AE or with a worsening of the pre-existing 
condition (e.g., for work-up of persistent pre-treatment lab abnormality) 
 
Protocol-specified admission during clinical study (e.g., for a procedure 
required by the study protocol) 
9.2.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours  
Scenarios involving exposure during pregnancy, exposure during breastfeeding, 
medication error, overdose, misuse, extravasation, lack of efficacy, and occupational 
exposure are described below. 
Exposure during pregnancy 
An exposure during pregnancy (EDP) occurs if: 

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1. A female becomes, or is found to be, pregnant either while receiving or having 
been  exposed to (e.g., environmental) Sayana®, or the female becomes, or is 
found to be, pregnant after discontinuing and/or being exposed to Sayana® 
(maternal exposure). 
An example of environmental exposure would be a case involving direct contact 
with a Pfizer product in a pregnant woman (e.g., a nurse reports that she is 
pregnant and has been exposed to chemotherapeutic products). 
2. A male has been exposed, either due to treatment or environmental exposure to 
Sayana® prior to or around the time of conception and/or is exposed during the 
partner pregnancy (paternal exposure). 
As a general rule, prospective and retrospective exposure during pregnancy reports from 
any source are reportable irrespective of the presence of an associated AE and  the 
procedures for SAE reporting should be followed. 
If a study participant or study participant’s partner becomes, or is found to be, pregnant 
during the study participant’s treatment with Sayana®, this information must be submitted 
to Pfizer, irrespective of whether an adverse event has occurred using the NIS AEM 
Report Form and the EDP Supplemental Form.  
In addition, the information regarding environmental exposure to Sayana® in a pregnant 
woman (e.g., a subject reports that she is pregnant and has been exposed to a cytotoxic 
product by inhalation or spillage) must be submitted using the NIS AEM Report Form 
and the EDP supplemental form. This must be done irrespective of whether an AE has 
occurred.   
Information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy). 
Follow-up is conducted to obtain general information on the pregnancy; in addition, 
follow-up is conducted to obtain information on EDP outcome for all EDP reports with 
pregnancy outcome unknown.  A pregnancy is followed until completion or until 
pregnancy termination (e.g., induced abortion) and Pfizer is notified of the outcome.  This 
information is provided as a follow up to the initial EDP report.  In the case of a live birth, 
the structural integrity of the neonate can be assessed at the time of birth.  In the event of 
a termination, the reason(s) for termination should be specified and, if clinically possible, 
the structural integrity of the terminated fetus should be assessed by gross visual 
inspection (unless pre-procedure test findings are conclusive for a congenital anomaly 
and the findings are reported). 
If the outcome of the pregnancy meets the criteria for an SAE (e.g., ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in 
a live born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
procedures for reporting SAEs should be followed. 
Additional information about pregnancy outcomes that are reported as SAEs follows:  
 Spontaneous abortion includes miscarriage and missed abortion; 

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 Neonatal deaths that occur within 1 month of birth should be reported, without 
regard to causality, as SAEs.  In addition, infant deaths after 1 month should be 
reported as SAEs when the investigator assesses the infant death as related or 
possibly related to exposure to investigational product 
Additional information regarding the exposure during pregnancy may be requested.  
Further follow-up of birth outcomes will be handled on a case-by-case basis (e.g., follow-
up on preterm infants to identify developmental delays).   
In the case of paternal exposure, the study participant will be provided with the Pregnant 
Partner Release of Information Form to deliver to his partner.  It must be documented that 
the study participant was given this letter to provide to his partner. 
Exposure during breastfeeding 
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence 
of an associated AE. An exposure during breastfeeding report is not created when a Pfizer 
drug specifically approved for use in breastfeeding women (e.g., vitamins) is 
administered in accord with authorized use.  However, if the infant experiences an AE 
associated with such a drug’s administration, the AE is reported together with the 
exposure during breastfeeding. 
Medication error 
A medication error is any unintentional error in the prescribing, dispensing or 
administration of a medicinal product  that may cause or lead to inappropriate medication 
use or patient harm while in the control of the health care professional, patient, or 
consumer.  Such events may be related to professional practice, health care products, 
procedures, and systems including: prescribing; order communication; product labeling, 
packaging, and nomenclature; compounding; dispensing; distribution; administration; 
education; monitoring; and use.   
Medication errors include: 
 Near misses, involving or not involving a patient directly (e.g., 
inadvertent/erroneous administration, which is the accidental use of a product 
outside of labeling or prescription on the part of the healthcare provider or the 
patient/consumer); 
 Confusion with regard to invented name (e.g., trade name, brand name). 
The investigator must submit the following medication errors to Pfizer, irrespective of the 
presence of an associated AE/SAE : 
 Medication errors involving patient exposure to the product, whether or not the 
medication error is accompanied by an AE. 
 Medication errors that do not involve a patient directly (e.g., potential medication 
errors or near misses).  When a medication error does not involve patient exposure 
to the product the following minimum criteria constitute a medication error report: 
− 
An identifiable reporter; 

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− 
A suspect product; 
− 
The event medication error. 
Overdose, Misuse, Extravasation 
Reports of overdose, misuse, and extravasation associated with the use of a Pfizer product  
are reported to Pfizer by the investigator, irrespective of the presence of an associated 
AE/SAE.  
Lack of Efficacy 
Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the investigator, 
irrespective of the presence of an associated AE/SAE or the indication for use of the 
Pfizer product. 
Occupational Exposure 
Reports of occupational exposure to a Pfizer product are reported to Pfizer by the 
investigator, irrespective of the presence of an associated AE/SAE. 
9.2.4. Medical Device Complaint Reporting Requirements 
All medical device complaints, regardless of whether the medical device complaint is 
associated with an AE, will be collected on the applicable pages within the CRF.  This 
includes potential near incident or malfunctions associated with the use of a medical 
device product.  A near incident or malfunction is an event that might have led to death or 
serious deterioration in health, or if it occurred again, might have led to death or serious 
deterioration in health. 
Pfizer is to be notified of all medical device complaints within 24 hours of awareness of 
the event by the investigator. 
Medical device complaints that are not associated with an SAE are forwarded to Pfizer 
Global Manufacturing. 
9.2.5. Communication of Issues 
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
Competent Authority in any area of the world, or if the investigator is aware of any new 
information which might influence the evaluation of the benefits and risks of Sayana®, 
Pfizer should be informed immediately.   
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study patients against any immediate hazard, and 
of any serious breaches of this NI study protocol that the investigator becomes aware of. 
9.3. Single reference safety document 
Investigator should use the single reference safety document (SRSD) for purpose of 
prescription and guidance checking.  

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Background information on Sayana® can be obtained from the current version of the local 
product document, which is the single reference safety document (SRSD) for information 
relating to Sayana® in this study. 
 
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS 
Pfizer fulfils its commitment to publicly disclose the results of studies through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov). Pfizer registers study 
protocols and posts Basic Results on ClincialTrials.gov for Pfizer-sponsored 
interventional studies that evaluate the safety and/or effectiveness of a Pfizer product and 
for Pfizer sponsored NI studies. 
The results are posted in a tabular format called Basic Results and the posting timelines 
are: 
 Newly FDA approved products: 
Basic Results must be submitted within 30 calendar days of the FDA marketing 
approval for studies whose PCD occurred prior to 1 anniversary year or more 
from the date of marketing approval. 
 FDA-previously approved products: 
Basic Results are due within 1 anniversary year of the PCD and/or LSLV. 
When PCD and LSLV are not the same date, Basic Results are posted 1 
anniversary year from the PCD and the record is updated 1 anniversary year from 
LSLV. PCD cannot occur after LSLV. 
 Discontinued products: 
Basic Results are due within 1 anniversary year of the decision to discontinue the 
product for all indications if there are no plans to out license the product or within 
2 anniversary years if out licensing plans are not completed. 
 Marketed outside of the United States (US) only: 
Basic Results are due within1 anniversary year of the ex-US approval or for 
already approved products, within 1 anniversary year of LSLV. 
For products marketed in the US and ex-US, the US timelines are followed. 
Primary Completion Date (PCD)  is defined as the date that the final subject was 
examined or received an intervention for the purposes of final collection of data for the 
primary outcome, whether the clinical trial concluded according to the pre-specified 
protocol, was terminated or ongoing. 

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11. REFERENCES 
1. 
Sharing Responsibility: Women, Society and Abortion Worldwide. 
www.guttmacher.org/pubs/sharing.pdf. Accessed June 24, 2008.  
2. 
Guttmacher Institute. Abortion in context: United States and worldwide.  
www.guttmacher.org/pubs/ib_0599.html. Updated May, 1999. Accessed June 24, 
2008.  
3. 
United Nations Population Fund. Contraceptive use rises, but unmet needs remain 
[press release]. www.unfpa.org/intercenter/hopes/contrac.htm. Accessed June 24, 
2008.  
4. 
FREEMAN S. J ACAD NURSE PRACT. 2004;16(6):226-238. 
5. 
Levine JP. J Fam Pract. 2004;53(11):904-913.  
6. 
Jain J, Dutton C, Nicosia A, Wajszczuk C, Bode FR, Mishell DR Jr. 
Pharmacokinetics, ovulation suppression and return to ovulation following a lower 
dose subcutaneous formulation of Depo-Provera®. Contraception. 2004;70(1):11-18.  
7. 
Westhoff C. Depot-medroxyprogesterone acetate injection (Depo-Provera®): a 
highly effective contraceptive option with proven long-term safety. Contraception. 
2003;68:75-87.  
8. 
Depo-Provera® Contraceptive Injection medroxyprogesterone  acetate injectable 
suspension, USP. Physician Information. New York, NY: Pfizer Inc; May 2006.  
9. 
US FDA Label 
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf 
10. Gerlinger C, Schumacher U, Wentzeck R, Uhl-Hochgraber K, Solomayer EF, 
Schmitz H, Faustmann T, Seitz C. How can we measure endometriosis-associated 
pelvic pain? J Endometriosis. 2012;4(3):109-116. 
 
12. LIST OF TABLES  
None. 
 
13. LIST OF FIGURES 
1. <Figure 1> Data Management Flow Chart 
2. <Figure 2> Data Validation Flow Chart 
3. <Figure 3> Visual Analogue Scale 

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ANNEX 1. LIST OF STAND-ALONE DOCUMENTS 
None. 
 
ANNEX 2. ADDITIONAL INFORMATION 
Not applicable.