Evaluation of the Effectiveness, Safety and Tolerability of the ContraMed VeraCept Intrauterine Copper Contraceptive for Long-Acting Reversible Contraception
Phase: PHASE2
Conditions: Contraception
Sponsor: Sebela Women's Health Inc.

COVER PAGE FOR CLINICALTRIALS.GOV 
 
Document 
 
Protocol 
 
Study Title 
 
Evaluation of the Effectiveness, Feasibility, Safety and Tolerability of the ContraMed VeraCept 
Intrauterine Copper Contraceptive for Long Acting Reversible Contraception 
 
NCT Number 
 
NCT02446821 
 
Sponsor 
 
 
 
Sebela Pharmaceuticals Development LLC 
 
Document Version 
Version 5.0 (September 19, 2017) 
 
Redaction Notice 
This document has been redacted in accordance with 42 CFR Part 11 to remove confidential 
commercial information and/or personal privacy information, where applicable. All 
modifications have been limited to protect proprietary data or personally identifiable information 
(PII). 
 
Notes 
This protocol is being submitted to ClinicalTrials.gov in compliance with the Final Rule for 
clinical trial results information reporting. 

Proprietary & Confidential 
ContraMed, LLC 
Document Number: 
CMDOC – 0008 
Revision: D 
Page: 1 of 1 
VeraCept Clinical Investigation Plan (US) 
Review & Approval: 
Name 
Position 
Signature 
Date 
Bob Katz 
President & 
CEO 
Doug Fujii 
Quality 
Assurance 
Sandra Matsumoto 
Regulatory 
Affairs 
Kevin Peters, PhD 
Clinical 
Affairs 
Clinical Investigation Plan CMDOC – 0008 Version 5.0 / 13 September 2017 Attached 45 pages 
DOCUMENT REVISION HISTORY 
Rev. 
Description 
Originator 
Effective Date 
A 
Initial Release 
B. Katz
8.30.14 
B 
Revised per FDA feedback 
B. Katz
2.17.15 
C 
Revised post Investigators Meeting 
B. Katz
7.9.15 
D 
Added subject contact at the end of 
each 28-day cycle post the 52 Week 
visit. 
M. Schreifels
9.19.17

ContraMed, LLC VeraCept Intrauterine Copper Contraceptive 
Phase II Feasibility Clinical Investigation Plan (CIP) 
CONTRAV MED 
Evaluation of the Effectiveness, Feasibility, Safety and Tolerability of the 
ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting 
Reversible Contraception 
Protocol Number: 
IND#: 
Version / Date: 
Sponsor: 
CMDOC-0008 
119743 
5.0 I 19 September 2017 
ContraMed LLC 
900 E. Hamilton A venue, Suite 100 
Campbell, CA 95008 
Principal Investigator: Anita Nelson, MD, Professor Obstetrics and Gynecology, 
David Geffen School of Medicine, Faculty and Staff, Harbor UCLA Medical Center 
This investigational protocol contains confidential and proprietary information provided 
by ContraMed to each Investigator in this clinical study. This information is intended for 
review and use by the Investigator, his/her staff, and the Ethics Committee and is not to 
be disclosed to others without the written permission of ContraMed, LLC. 
CONFIDENTIAL- May not be reproduced or distributed without written permission from 
ContraMed, LLC. 
CMDOC-0008 Version 5.0 / 19 September 2017 
Confidential 
Page 1 of 44 

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SIGNATURE PAGE 
By signing below, I confirm that I have read and will abide by this protocol, the signed 
investigator agreement and all applicable regulations.  
 
 
 
Investigator’s Name (print) 
 
 
Investigator’s Signature 
 
Date(DD/MMM/YYYY) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ContraMed, LLC VeraCept Intrauterine Copper Contraceptive 
Phase II Feasibility Clinical Investigation Plan (CIP) 
 
 
CMDOC-0008 Version 5.0 / 19 September 2017 
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Page 3 of 44 
Table of Contents 
 
REVISION HISTORY ............................................................................................................................... 6 
INVESTIGATIONAL PLAN SUMMARY ............................................................................................... 7 
ABBREVIATIONS AND DEFINITIONS OF TERMS ...................................................................... 12 
1. INTRODUCTION .............................................................................................................................. 14 
2. STUDY DURATION .......................................................................................................................... 16 
3.  INVESTIGATIONAL PRODUCT DESCRIPTION ...................................................................... 16 
4.  STUDY TREATMENTS ................................................................................................................... 17 
4.1 VERACEPT INTRAUTERINE COPPER CONTRACEPTIVE (DOSAGE AND 
FORMULATION) ................................................................................................................................... 17 
4.2 VERACEPT SUPPLY AND ADMINISTRATION ...................................................................... 17 
4.3 VERACEPT STORAGE AND ACCOUNTABILITY ................................................................... 17 
4.4 VERACEPT DOSAGE MODIFICATION ..................................................................................... 18 
4.5 CONCOMITANT THERAPY ......................................................................................................... 18 
4.6 VERACEPT RETENTION COMPLIANCE .................................................................................. 18 
5. OBJECTIVES ...................................................................................................................................... 18 
5.1 PRIMARY OUTCOME MEASURE ............................................................................................... 18 
5.2 SAFETY AND OTHER OUTCOME MEASURES ....................................................................... 18 
6.0 BENEFITS AND RISKS ................................................................................................................. 19 
6.1 POTENTIAL BENEFITS................................................................................................................ 19 
6.2 POTENTIAL RISKS / ADVERSE REACTIONS ........................................................................ 19 
6.3 MINIMIZATION OF ANTICIPATED RISKS ............................................................................. 20 
7. SELECTION AND TRAINING OF CLINICAL SITES AND INVESTIGATORS ....................... 20 
7.1 LABORATORIES ............................................................................................................................ 21 
8. STUDY POPULATION ..................................................................................................................... 22 
8.1 INCLUSION ...................................................................................................................................... 22 
8.2 EXCLUSION ..................................................................................................................................... 22 
9. INFORMED CONSENT .................................................................................................................... 24 
10. ENROLLMENT ................................................................................................................................ 24 
12. STUDY PROCEDURES .................................................................................................................. 27 
12.1 VISIT 1: SCREENING .................................................................................................................. 27 
12.2 VISIT 2: VERACEPT PLACEMENT (DAY 1) ......................................................................... 27 
12.3 VISITS 3-6 (WEEK 6±2,13±2, 26±2 AND 52±2/ EXIT AFTER VERACEPT 
PLACEMENT TO WEEK 52) .............................................................................................................. 28 

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12.3.1 MONTHLY PHONE CONTACT (UP TO 52 WEEKS) ....................................................... 29 
12.4 LONG-TERM FOLLOW-UP POST 52-WEEK VISIT (EVERY 6 MONTHS:  MONTHS 
18-30 (±4WKS) AND 3 YRS (-3WKS/+4WKS) /EXIT VISIT ................................................... 29 
12.4.1 END OF EACH 28-DAY CYCLE CONTACT (POST 52 WEEKS + 1 W) ........................ 30 
12.5 EARLY DISCONTINUATION VISIT ........................................................................................ 30 
12.6 UNSCHEDULED VISITS ............................................................................................................. 30 
12.7 EMERGENCY CONTRACEPTION ............................................................................................ 31 
13. DIARIES ........................................................................................................................................... 31 
14. 
CONCOMITANT MEDICATIONS ........................................................................................... 31 
15. ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ....................................................... 31 
15.1 DEFINITION OF A SERIOUS ADVERSE EVENT .................................................................. 31 
15.2 DEFINITION OF AN ADVERSE EVENT ................................................................................. 32 
15.3 CAUSALITY: SERIOUS ADVERSE EVENT AND ADVERSE EVENT RELATIONSHIP TO 
STUDY TREATMENT........................................................................................................................... 32 
15.3.1 CLARIFICATION OF ADVERSE EVENTS RELATED TO STUDY PROCEDURES ..... 33 
15.4 SERIOUS ADVERSE EVENT AND ADVERSE EVENT SEVERITY .................................... 33 
15.5 ADVERSE EVENT OUTCOME .................................................................................................. 33 
15.6 PROMPT REPORTING OF SAES TO SPONSOR .................................................................. 34 
15.7 CLINICAL LABORATORY ABNORMALITIES AND OTHER ABNORMAL 
ASSESSMENTS AS ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ........................... 35 
15.8 DOCUMENTING ADVERSE EVENTS ...................................................................................... 36 
15.9 FOLLOW-UP OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ..................... 36 
15.10 CLARIFICATION IN REPORTING OF DEATHS ................................................................ 36 
15.11 POST-STUDY TREATMENT REPORTING REQUIREMENTS ....................................... 36 
15.12 STUDY DEVICE MALFUNCTION .......................................................................................... 36 
16. PROTOCOL VIOLATIONS AND DEVIATIONS ....................................................................... 37 
17. SUBJECT CONFIDENTIALITY .................................................................................................... 37 
18. PREGNANCY DETERMINATION AND FOLLOW UP ............................................................ 37 
19. DATA MONITORING AND QUALITY CONTROL................................................................... 38 
19.1 MONITORING OF CLINICAL SITES AND INVESTIGATORS ............................................ 38 
19.2 ELECTRONIC CASE REPORT FORMS (ECRF) ..................................................................... 38 
19.3 DATA COLLECTION AND MANAGEMENT ........................................................................... 39 
19.4 MAINTAINING RECORDS ......................................................................................................... 39 
19.5 RECORD RETENTION ............................................................................................................... 39 
19.6 INVESTIGATIONAL PRODUCT ACCOUNTABILITY .......................................................... 39 

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19.7 STUDY CLOSEOUT ..................................................................................................................... 39 
19.8 AUDITS AND INSPECTIONS .................................................................................................... 39 
19.9 ANNUAL, INTERIM AND FINAL REPORT ............................................................................ 40 
20. STATISTICAL METHODOLOGY AND ANALYSIS .................................................................. 40 
20.1 ANALYSIS POPULATIONS ....................................................................................................... 40 
20.2 DISPOSITION OF SUBJECTS .................................................................................................... 40 
20.3 DEMOGRAPHIC AND OTHER SUBJECT CHARACTERISTICS ........................................ 40 
20.4 EXTENT OF EXPOSURE ............................................................................................................ 40 
20.5 PRE-TRIAL AND CONCOMITANT MEDICATIONS ............................................................ 40 
20.6 PRIMARY OUTCOME ................................................................................................................. 41 
20.7 SAFETY AND OTHER OUTCOME MEASURES .................................................................... 41 
20.8 MONITORING OF SAFETY AND PREGNANCY .................................................................... 42 
APPENDIX 1. INVESTIGATOR RESPONSIBILITIES ................................................................... 43 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATIONAL PLAN SUMMARY 
 
Title: 
Evaluation of the Effectiveness, Safety and Tolerability of the 
ContraMed VeraCept Intrauterine Copper Contraceptive for 
Long-Acting Reversible Contraception 
Protocol #: 
 
CMDOC-0008 
Version 5.0 / 19 September 2017 
 
 
Device Name: 
VeraCept Intrauterine Copper Contraceptive (referred to as 
VeraCept 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 VeraCept to support commencing a Phase III 
Clinical Study 
Study Duration: 
Subject enrollment will take approximately 4 months. Each 
subject will be followed for 12 months after device placement for 
the protocol endpoints, and then every 6 months thereafter for 
those subjects who wish to continue study device use 
 
Enrollment: 
Up to 250 subjects will be consented, screened and have 
VeraCept 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 up to 14 centers in the U.S 
 
 
Follow-up:  
Physical assessment (office visit) will occur at weeks 6, 13, 26 
and 52 after placement, with monthly telephone 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 VeraCept removal to become pregnant will 
be followed to pregnancy or until the subject changes her mind 
about trying to get pregnant.  All subjects in whom VeraCept is 
removed prior to 12 months, 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 

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sponsor as a contraceptive option during this time unless the 
subject has a category 4 condition precluding their use.  
 
Study Population: 
Pre-menopausal women ages 18 – 40, at risk for pregnancy, who 
are interested in using an 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 by 12 months, failure will be calculated by 
the Pearl Index. 
 
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 ± 5 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 to coitus at least once monthly during the study 
period. 
5. 
Married or in a steady relationship (e.g., 3-6 months); 
6. 
Seeking to avoid pregnancy for the next 12 months; 
7. 
Willing to use the study device as the sole form of contraception; 

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8. 
Willing to accept a risk of pregnancy;  
9. 
Normal PAP or ASC-US with negative high risk HPV test result within the 
appropriate screen timeframe, unless considered at risk; 
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 VeraCept 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 or 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; 
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;  
13. 
Known anatomical abnormalities of the uterine cavity 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. 
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;  
15. 
Current or recent (within the last 3 months) pelvic infection (cervix, 
endometrium, or fallopian tubes), or mucopurulent cervicitis; 

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16. 
High risk for STDs (e.g., multiple sexual partners); 
17. 
Known or suspected AIDS; 
18. 
Known intolerance or allergy to nickel or copper, including Wilson’s Disease; 
19. 
Currently participating or planning future participation in a research study of an 
investigational drug or device during the course of this investigational study; 
20. 
Subject had VeraCept placed previously or had 2 attempts at placement; 
21. 
Known or suspected alcohol or drug abuse within 12 months prior to the 
screening visit; 
22. 
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. 
 
Note:  If subject has a current IUD that is being removed; if subject had monthly 
menses, you do not need to wait any amount of time between removal of her first IUD 
and placement of VeraCept – however, if pain is present you should wait until pain has 
resolved with prior IUD before insertion of Veracept.  It is however suggested the 
subject have a return of menses if she had amenorrhea prior to placement.  
 
 
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 diary data, and were not pregnant 
before the IUD was placed.  
 
Effectiveness will be evaluated as the absence of pregnancy during VeraCept use for 
up to12 months.  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 through 12 months 
for cycles in subjects aged 18-35 at the time of study device placement, excluding the 
following cycles (unless the subject became pregnant in the cycle): 
• When back-up contraceptive or emergency contraceptive use was documented on 
the daily diary  
• 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. Secondarily the 
Pearl index and life table analyses will be done through 3 years.  
 
 
Safety and Other Outcome Measures 
 
VeraCept ease of placement, removal and placement success will be descriptively 
summarized. 
 

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Safety evaluations will be based on the incidence of adverse events and serious 
adverse events changes from baseline in other assessments (examinations and vital 
signs) and by relationship to the study device or study device placement procedure.  
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 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 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 average10 evaluable cycles of VeraCept use 
• 
1% of subjects will not provide any 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 
 

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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 

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mm 
Millimeter 
NDA 
New Drug Application 
NIH 
National Institutes of Health 
N/A 
Not Applicable 
OC 
Oral Contraceptive(s) 
Pap Test 
Papanicolaou Test 
PD 
Pharmacodynamics 
PK 
Pharmacokinetics 
PP 
Per-protocol 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
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 
 
 
 

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1. INTRODUCTION 
The VeraCept Intrauterine Copper Contraceptive is designed as a birth control device. 
There are over 62 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% of women.2 The CHOICE Study showed 
that the pill failure rate is 17-20 times higher than the failure rate with intrauterine 
devices.3,4  
Intrauterine devices 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 
LNG-IUS (Mirena®) is also associated with early complaints of irregular bleeding 
patterns, cramping pelvic pain and with amenorrhea. First year discontinuation rates for 
Copper IUDs in most studies range from 4-15%.5,6,7  
With high unintended pregnancy rates in the U.S. (49%)1, additional effective, safe and 
long-acting reversible contraceptives are needed. An intrauterine device with low-dose 
copper that achieves high contraceptive effectiveness, minimizes side effects and has 
improved mechanical advantages could offer an attractive option to women seeking 
effective protection against unintended pregnancy. We believe the VeraCept 
Intrauterine Copper Contraceptive embodies these advantages. 
Pilot Study of the VeraCept Intrauterine Copper Contraceptive 
 
A Pilot Study of the VeraCept Intrauterine Copper Contraceptive in a population of 
parous women enrolled at a single site demonstrated the safe use of the study device in 
                                                          
1Alan Guttmacher Institute Fact Sheets Oct 2013 (www.guttmacher.org) 
2 Jones J, Mosher WD and Daniels K, Current contraceptive use in the United States, 2006–2010, and changes in  
patterns of use since 1995, National Health Statistics Reports, 2012, No. 60, 
<http://www.cdc.gov/nchs/data/nhsr/nhsr060.pdf>, 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 Winner, B; Peipert, JF; Zhao, Q; Buckel, C; Madden, T; Allsworth, JE; Secura, GM. (2012), "Effectiveness of Long-
Acting Reversible Contraception", New England Journal of Medicine 366 (21): 1998–2007, 
doi:10.1056/NEJMoa1110855 
5 Speroff L, Darney PD. A Clinical Guide for Contraception. 4th ed. Philadelphia: Lippincott Williams and Wilkins; 2005 
6 The TCu380A IUD and the frameless IUD “the FlexiGard”: interim three-year data from an international multicenter trial: 
UNDP, UNFPA, and WHO Special Programme of Research, Development and Research Training in Human 
Reproduction, World Bank: IUD research group. Contraception. 1995;52:77–83. [No author listed] 
7 Hubacher D, Reyes V, Lillo S, et al. Preventing copper intrauterine device removals due to side effects among first-time 
users: randomized trial to study the effect of prophylactic ibuprofen. Hum Reprod. 2006;21: 1467–1472 
 

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approximately 463 subjects total in two phases of the study, representing approximately 
6,706 combined women-months (558 women-years) of experience. 
 
In this time period, there were no serious adverse events due to the study device or its 
placement. Discontinuation rate due to tolerability was low. There have been no 
intrauterine pregnancies over the course of the study to date, and one serious adverse 
event (an ectopic pregnancy) early in the Phase I portion of the study. 
 
VeraCept was successfully placed in all enrolled subjects with no peri-procedural 
adverse events and without the use of anesthetics, pre-medication or mechanical 
dilatation. The VeraCept Intrauterine Copper Contraceptive, in this initial experience, 
satisfied the objectives of providing a safe, easy to place, conformable low-dose copper 
contraceptive that is highly tolerated.  
In the Phase II Confirmation portion of the Pilot Study, the Subject Continuation Rate is 
90% at 10 months, with only 2% expulsion rate and 3% discontinuation for tolerability. 
The remaining 5% discontinued due to other reasons (e.g. the desire to get pregnant or 
inability to comply with study follow-up requirements.)  
Comparative Study of the VeraCept Intrauterine Copper Contraceptive 
 
Subsequent to the Pilot Study, a 2:1 randomized, subject-blinded Comparative Study of 
the VeraCept Intrauterine Copper Contraceptive vs. the TCu380 IUD is being 
conducted in a population of parous women enrolled at a single site.  The interim 
results to date demonstrate that VeraCept has achieved equivalent performance in 
terms of safety and effectiveness as compared to the predicate TCu380 IUD, i.e. no 
serious adverse events and no intrauterine or ectopic pregnancies in either group, while 
achieving clinically and statistically significant improvements in subject-related 
outcomes such as improved tolerability, reduced expulsions and reduced pain-at-
insertion.  
 
 
VeraCept was successfully placed in 99.5% of all subjects to whom the study device 
was randomly assigned, with no peri-procedural adverse events, and without the use of 
anesthetics, pre-medication or mechanical dilatation. No new or unanticipated adverse 
events were introduced. Statistically significant improvements (95% CI) in Subject 
Continuation Rate, Tolerability, Study Device Expulsion and Pain at Insertion were all 
demonstrated when compared to the control intrauterine device. 
 
In this experience to date, VeraCept satisfied the objectives of providing a safe, easy to 
place, conformable low-dose intrauterine copper contraceptive without sacrificing safety 
or effectiveness. Study completion to 12 months and, subsequently, a larger multicenter 
study is warranted. 
 
This Phase II Clinical Study is designed to evaluate the effectiveness, study device 
placement, safety, and tolerability of VeraCept to support a larger, Phase III clinical 
study. 
 

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Figure 2 – (a) VeraCept in pre-loaded state    (b) orientation in the uterus post  
placement 
4.  STUDY TREATMENTS 
 
After the risks and benefits of study participation have been explained to the candidate, 
her questions have been answered, she has signed a written consent and PHI form, 
and eligibility has been established, a subject identification number will be assigned by 
the Study Sponsor or designee.  If subject has a current IUD that is being removed; if 
subject had monthly menses, you do not need to wait any amount of time between 
removal of her first IUD and placement of VeraCept – however, if pain is present you 
should wait until pain has resolved with prior IUD before insertion of Veracept.  It is 
however suggested the subject have a return of menses if she had amenorrhea prior to 
placement.  
 
4.1 VeraCept Intrauterine Copper Contraceptive (Dosage and Formulation) 
VeraCept contains 175mm2 exposed copper surface area. A single VeraCept design 
and dosage will be used in this study. VeraCept will be supplied by ContraMed LLC.  
For further details, see the VeraCept Intrauterine Copper Contraceptive Investigator’s 
Brochure. 
4.2 VeraCept Supply and Administration 
Each VeraCept is preloaded in the inserter and packaged as a single use sterile 
system. Subjects will have VeraCept placed on “Day 1” of the trial.  VeraCept should be 
stored in its sterile sealed package until study device placement. 
See the Investigator’s Brochure for a more detailed VeraCept product description, and 
the VeraCept labelling for placement and removal instructions.   
4.3 VeraCept Storage and Accountability 
VeraCept should be stored at 25°C (77°F), with excursions permitted between -20 °C to 
+50°C (-4F to 122F) [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 

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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. 
4.4 VeraCept Dosage Modification 
All subjects will receive the same VeraCept dosage of 175mm2 exposed copper surface 
area. No Study Devices will be replaced if an expulsion or removal occurs.  
4.5 Concomitant Therapy 
Concomitant medications are any prescription medications or over-the-counter 
preparations used by the subject taken from the time the subject signs the informed 
consent documents until Study Exit.  All concomitant medications, including excluded 
therapies, must be documented in the Concomitant Medication eCRF. 
4.6 VeraCept 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 VeraCept Intrauterine Copper 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 an Investigational New Drug (IND) application to the U.S. Food and Drug 
Administration (FDA) for a longer-term Phase III Pivotal Clinical Study. 
5.1 Primary Outcome Measure 
The primary outcome measure is effectiveness, evaluated as the absence of 
pregnancy by up to12 months of VeraCept use. Failure will be calculated using the 
Pearl Index through 12 months. All evaluable cycles prior to discontinuation or 
planned removal at 12 months 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 
 

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Safety; 
- 
Serious Adverse Events  
- 
Adverse Events 
 
Tolerability: 
- 
Bleeding and spotting patterns 
- 
Discontinuation rate 
6.0 BENEFITS AND RISKS 
6.1 Potential Benefits 
No assurances or guarantees can be made regarding the benefits of VeraCept to 
the study subject. The potential benefits of VeraCept include that it is a non-
hormonal contraceptive method that requires only professional placement to be 
effective. 
6.2 Potential Risks / Adverse Reactions 
The following AEs have been reported in >2% of subjects in the first year of the 
VeraCept Phase II study, CMDOC-0008: 
 
• 
Dysmenorrhoea 
• 
Procedural pain 
• 
Menorrhagia 
• 
Nasopharyngitis 
• 
Headache 
• 
Abdominal pain 
• 
Upper respiratory tract infection 
• 
Metrorrhagia 
• 
Pelvic pain 
• 
Bacterial vaginosis 
• 
Urinary tract infection 
• 
Back pain 
• 
Vulvovaginal mycotic infection 
• 
Uterine spasm 
• 
Dyspareunia 
• 
Abdominal pain lower 
• 
Post procedural haemorrhage 
• 
Vaginal discharge 
• 
Nausea 
• 
Oropharyngeal pain 
• 
Abdominal distension 
• 
Sinusitis 
• 
Influenza 
• 
Insomnia 

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• 
Pharyngitis streptococcal 
• 
Cough 
• 
Diarrhoea 
• 
Migraine 
• 
Toothache 
• 
Vomiting 
• 
Arthralgia 
• 
Breast tenderness 
• 
Dizziness 
• 
Vaginal odour 
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 VeraCept 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; 
 
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. 
 
7. SELECTION AND TRAINING OF CLINICAL SITES AND INVESTIGATORS 
The study will be conducted at up to 14 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.  The site qualification visit will be scheduled to include time with 
the Principal Investigator, co-investigators, study coordinator, and other study personnel 

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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. 
• 
Complete training on use of the Case Report Forms (eCRFs) provided by 
ContraMed representative or designee. 
• 
Review and are familiar with VeraCept Prescribing Information. 
• 
Complete training with VeraCept, 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. 

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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.  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 ± 5 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 to have coitus at least once monthly during 
the study period 
5. 
Married or in a steady relationship (e.g., 3-6 months); 
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. 
Normal PAP or ASC-US with negative high risk HPV test result within the 
appropriate screen timeframe, unless considered at risk  
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 
VeraCept 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 or complete uterine 
involution; 

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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; 
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;  
13. 
Known anatomical abnormalities of the uterine cavity that may 
complicate IUD placement, such as: 
13.1 
Submucosal uterine leiomyoma 
13.2 
Asherman’s syndrome 
13.3 
Pedunculated polyps 
13.4 
Bicornuate uteru 
13.5 
Didelphus or uterine septa 
14. 
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;  
15. 
Current or recent (within the last 3 months) pelvic infection (cervix, 
endometrium, or fallopian tubes), or mucopurulent cervicitis; 
16. 
High risk for STDs (e.g., multiple sexual partners); 
17. 
Known or suspected AIDS; 
18. 
Known intolerance or allergy to nickel or copper, including Wilson’s 
Disease; 
19. 
Currently participating or planning future participation in a research study 
of an investigational drug or device during the course of this 
investigational study; 
20. 
Subject had VeraCept placed previously or had 2 attempts at placement; 
21. 
Known or suspected alcohol or drug abuse within 12 months prior to the 
screening visit; 
22. 
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. 
 
Note that a subject changing from an oral contraceptive, IUD or implantable 
contraceptive does not need to wait before switching to VeraCept subject to the criteria 
above.  If subject has a current IUD that is being removed; if subject had monthly 
menses, you do not need to wait any amount of time between removal of her first IUD 
and placement of VeraCept – however, if pain is present you should wait until pain has 
resolved with prior IUD before insertion of VeraCept.  It is however suggested the 
subject have a return of menses if she had amenorrhea prior to placement.  
 

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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. 
 
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.  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 with the candidate in her native language 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.  The PHI and Subject Bill of Rights forms must also be signed by the candidate 
prior to study participation. 
 
10. ENROLLMENT 
A subject is considered enrolled into the study after signing the informed consent, PHI 
and Bill of Rights forms and being found eligible based on her history, physical 
examination and screening tests. If an eligible consented patient withdraws consent 
before insertion for any reason this would be considered a screen failure.  
 
 

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11. STUDY SCHEDULE OF ASSESSMENTS 
The study schedule of assessments is provided in Table 1. 
 
 
Table 1. Study Schedule of Assessments 
 
 
Visit 1 -  Screen 
Visit 2-  (VeraCept Placement) Day 1 
Visit 3  - Follow up  Week 6 ± 2 
Visit 4 – Follow up Week 13 ± 2 
Visit 5 – Follow up Week 26 ± 2 
Visit 6 – Follow up Week 52 ± 2 / Exit 
Phone Visit (Optional) up to 52 
Weeks 
Monthly Phone Contact up to 52 
Weeks 
Long-term FU post 52-week visit 
(Every 6 Months 18-30 (±4wks) and 3 
yrs (-3wks/+4wks) /Exit visit 
End of each 28-day Cycle Contact  
(Post 52 Wks ± 1w) 
 Initiation/Subject Characteristics 
 
 
 
 
 
Assessment of Eligibility 
X 
X 
 
X 
 
 
 
Distribution of information 
X 
 
 
 
 
 
Informed consent, PHI and Bill of 
Rights forms 
X 
 
 
 
 
 
Demographics and baseline 
characteristics 
X 
 
 
 
 
 
Medical/surgical, gynecologic 
and menstrual history 
X 
 
 
 
 
 
Safety and Effectiveness 
 
 
 
 
 
Vital signs and weight 
X 
X 
X 
X 
X 
X 
 
 
X 
 
Height 
X 
 
 
 
 
 
General physical exam 
X 
X 
X 
X 
X 
X 
 
 
X 
 
Pelvic exam  
X 
X 
X1 
X1 
X1 
X1 
 
 
X1 
 
Cervical cytology 
X 
 
 
 
 
 
Cervical infection tests 
 
X6 
 
 
 
 
 
Transvaginal ultrasound (for verifying 
study device position) 
X 
X2 
X2 
X2 
X 
 
 
X2 
 
Pregnancy test-urine 
X 
X 
X 
X 
X 
X 
X4 
 
X 
X 
 
Prior and interval concurrent 
medication 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Adverse events 
X 
X 
X 
X 
X 
 
X 
X 
 
 
 
 

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Visit 1 -  Screen 
Visit 2-  (VeraCept Placement) Day 1 
Visit 3  - Follow up  Week 6 ± 2 
Visit 4 – Follow up Week 13 ± 2 
Visit 5 – Follow up Week 26 ± 2 
Visit 6 – Follow up Week 52 ± 2 / 
Exit 
Phone Visit up to 52 Weeks 
(Optional) 
Monthly Phone Contact 
up to 52 Weeks  
Long-term FU post 52-week visit 
(Every 6 Months 18-30 (±4wks) and 
3 yrs (-3wks/+4wks) /Exit visit 
End of each 28-day Cycle Contact  
(Post 52 Weeks ± 1 w) 
Other 
 
 
 
 
 
 
 
 
 
 
IUD placement ease 
X 
 
 
 
 
IUD placement pain 
X 
 
 
 
 
IUD removal ease 
X 
 
 
 
IUD removal pain 
X 
 
 
 
Concomitant contraception 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Need for contraception (intercourse) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Diary dispensing 
X3 
X 
X 
X 
X 
 
 
 
 
Diary collected/reviewed with patient 
(subject) 
X3 
X 
X 
X 
X 
 
X 
 
End of study medication 
X 
 
 
 
 
Note: Screening and enrollment visit may be combined if the patient requests and all labs and 
screening exams are documented as normal. 
 
1    Pelvic exam for VeraCept string check 
2   Transvaginal Ultrasound only if indicated 
3 
First Diary Dispensing and Collection, prior to VeraCept placement, to be used as training 
with the subject.  This diary data is not a part of data collection or analysis.  It is intended to 
ensure the subject understands how to complete the 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 VeraCept is removed before 52+2 weeks, Visit 6 activities should be completed 
for Exit Visit. 
5 
Screening for cervical infection tests are to be done at screening unless these tests have 
been previously completed within three months of the screening visit. Results must be 
negative. 
 
 

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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, if indicated or last test out of date 
• 
Cervical infection tests (gonorrhea and Chlamydia) 
• 
Pregnancy test 
• 
Prior and concurrent medications 
Diaries and instructions will be dispensed to the subject for completion leading up 
to the day of VeraCept placement. This set of diaries is intended for training 
purposes and will not be included in the data analysis. 
12.2 Visit 2: VeraCept Placement (Day 1) 
VeraCept can be placed on any day of the menstrual cycle. Subjects must have 
a negative urine pregnancy test just prior to VeraCept placement.  Initiation of 
the VeraCept is consistent with standard IUD placement.  Refer to the 
Prescribing Information for specific instructions. 
 

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If placement is unsuccessful, a second attempt may be made 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 VeraCept 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 VeraCept placement, the following evaluations will be completed: 
• 
Entry criteria confirmed  
• 
Vital signs and weight 
• 
Physical Exam 
• 
Pelvic Exam 
• 
Pregnancy test, urine 
• 
Prior and concurrent medications 
• 
Any adverse events. 
Following VeraCept placement, evaluations will be made for: 
• 
VeraCept placement ease 
• 
VeraCept placement pain 
• 
VeraCept position (evaluated by Transvaginal Ultrasound) 
• 
Concomitant contraception 
• 
Need for contraception if VeraCept was not properly placed 
Study site staff will review the completed 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. 
 
New diaries will be dispensed to the subject at this time, along with instructions 
for proper completion of the diaries. 
 
12.3 Visits 3-6 (Week 6±2,13±2, 26±2 and 52±2/ Exit after VeraCept 
placement to week 52) 
The subject will return for follow up visits at preplanned intervals following 
placement of the VeraCept.  At these follow up visits, the subject will be 
evaluated for: 
• 
Vital signs and weight 
• 
General physical exam (same as at Screening Visit) 
• 
Pelvic exam (string check) 
• 
Pregnancy test, urine 
• 
Interval and concurrent medications 
• 
Adverse events 
• 
Diary collection and review with subject 
o Verify sexual activity and any back-up method is documented 

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• 
Diary dispensing  
Additionally, at the Week 52 / Exit visit, the following will also be performed: 
• 
Transvaginal ultrasound to document VeraCept position 
• 
VeraCept Removal 
o VeraCept removal ease 
o VeraCept 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. 
 
At 52 weeks, subjects will be allowed to continue with the study device with an 
office follow-up visits every 6 months for a maximum of three years post study 
device placement). 
A 2-week supply of hormonal contraceptive pills will be provided to the subject 
by the site as a contraceptive option for the first two weeks after VeraCept 
removal. 
12.3.1 Monthly Phone Contact (up to 52 Weeks) 
Subjects will be contacted by phone each month, after her menses, to 
confirm completion of the monthly diary for: 
• 
The need for additional contraception; 
• 
Use of concomitant contraception; 
• 
Use of concomitant medications; 
• 
Documentation of menstrual and intermenstrual bleeding;  
• 
Assess if there have been any adverse events since the last 
contact; and 
• 
Resolution of any prior serious adverse events or adverse 
events. 
12.4 Long-term Follow-up post 52-week visit (Every 6 Months:  
Months 18-30 (±4wks) and 3 yrs (-3wks/+4wks) /Exit visit 
The subject will return for follow up after their Week 52 visit, every 6 months, if 
they choose to continue with the study visit. During these visits, the subject will 
be evaluated for: 
• 
Vital signs and weight 
• 
General physical exam (same as at Screening Visit) 
• 
Pelvic exam (string check) 
• 
Transvaginal ultrasound to document VeraCept position (only if 
indicated) 
• 
Pregnancy test, urine 
• 
Interval and concurrent medications 
• 
Adverse events 
• 
Verify sexual activity 

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• 
Document any back-up contraception methods 
Additionally, at the final visit at 3 Years / Exit visit, the following will also be 
performed: 
• 
Transvaginal ultrasound to document VeraCept position 
• 
VeraCept Removal 
• 
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. 
A 2-week supply of hormonal contraceptive pills will be provided to the subject 
by the site as a contraceptive option for the first two weeks after VeraCept 
removal. 
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. The 
cycle is determined from the day of VeraCept insertion: 
o Verify sexual activity 
o Document any back-up contraception methods 
12.5 Early Discontinuation Visit 
Subjects who request removal of VeraCept before 12 months will be required to 
use an alternative contraceptive for the first two weeks following removal.  A 
two-week supply of Hormonal contraceptive pills will be provided by the site as a 
contraceptive option during this time. 
If a subject requests VeraCept 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 VeraCept removal.  The subject will be followed until 
resolution of the event or 30 days after removal, whichever occurs first.  Subjects 
experiencing an on-going adverse event will continue to receive the appropriate 
follow-up medical care. 
 
If a subject requests early discontinuation and VeraCept removal to become 
pregnant, the Study Exit Visit described in Section 12.3 above should be 
completed and documented on the CRF at the time of VeraCept 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 phone contact and documented on 
the phone contact form.   
12.6 Unscheduled Visits 
Unscheduled visits must be documented on a follow-up visit CRF.  Medical 
evaluations will be conducted as indicated by the reason for the unscheduled 
visit. 

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12.7 Emergency Contraception 
If the subject suspects the VeraCept has expelled, she should contact the study 
site. 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.   
 
13. Diaries 
Subjects will be instructed to complete diaries daily.  Diaries are designed to collect the 
following information for each day of each menstrual cycle: 
• 
Day of cycle 
• 
Date 
• 
Absence or presence of menstrual or other bleeding (none, spotting, normal or 
heavy) 
• 
VeraCept expulsion (yes, no, suspected) 
• 
Usage of additional birth control methods and type of birth control used 
• 
Presence of abnormal pain or cramping 
• 
Other medical problems 
• 
All medications taken that day 
• 
Frequency of intercourse 
• 
Liner, pad and tampon usage 
 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 and 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. Subjects will also be required to record AEs on their daily diary. For the 
Sponsor to fulfill safety assessment obligations, the Investigator must 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 situation (subject is at immediate risk of death); 

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• 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. 
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).  
 

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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 usually 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. 
15.5 Adverse Event Outcome 
 
The Investigator will categorize the outcome of each SAE and AE according to 
the definitions below: 

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• 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 and the Investigator determines that an 
adverse event meets the protocol definition of an SAE. 
 
All SAEs occurring from the beginning of study entry 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 

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but should provide as much relevant information as immediately available. 
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 VeraCept 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 

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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. 
 
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.   

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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 on the case report forms 
(eCRFs). 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.   
 
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.  Pregnancies will be promptly 

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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.   
 
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. 

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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 VeraCept 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. 
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. 

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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. 
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 diary with intercourse and without any 
backup contraception or emergency contraception (EC) 
OR 
4. became pregnant while VeraCept 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 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 VeraCept 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 

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study.  Pre-trial medications include any routine medications taken within 30 
days of enrollment.  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 VeraCept use for up to 12 months. 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 through 12 months for cycles in subjects 
aged 18-35 at the time of VeraCept placement, excluding the following (unless 
the subject became pregnant in the cycle): 
• Cycles where back-up contraception use was documented on the daily diary  
• Cycles with no intercourse.   
• Cycles in which emergency contraception was used 
The EP population will be used for the primary evaluation of effectiveness. 
Life table analyses will be used as further assessment of pregnancies.  
Secondarily the Pearl index and life table analyses will be done through 3 years. 
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. 
 
VeraCept 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 
VeraCept 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: 
• 
Anemia 
• 
Back pain 
• 
Dysmenorrhea 
• 
Dyspareunia 
• 
Ectopic pregnancy  
• 
Embedment, which in some cases may require surgical removal 

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• 
Expulsion, partial or complete 
• 
Intrauterine pregnancy 
• 
Leukorrhea 
• 
Medical diathermy 
• 
Menstrual flow, prolonged / vaginal bleeding 
• 
Menstrual spotting 
• 
Movement of study device during MRI 
• 
Pain and cramping 
• 
Pelvic infection, which can lead to Fallopian tubal damage leading to 
ectopic pregnancy or infertility, hysterectomy, sepsis and rarely death 
• 
Pelvic Inflammatory Disease (PID), which can lead to tubal damage 
leading to ectopic pregnancy or infertility, or infrequently can necessitate 
hysterectomy, or cause death. 
• 
Uterine perforation, which may lead to pre-operative imaging followed by 
laparscopy or laparotomy to remove the IUD from the peritoneal cavity 
• 
Septic abortion 
• 
Uticarial allergic skin reaction 
• 
Vaginitis 
• 
Vasovagal reaction at the time of placement, including fainting. 
 
VeraCept Safety-Related Removal Rates and Expulsion Rates 
Cumulative VeraCept 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 diary. 
The ECYC population 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. 
  
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. 
 
 

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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 

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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.