Conditions: Contraception
Keywords: oral contraceptive contraceptive implant contraception adherence adverse event
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: yes

Brief summary:
Women currently using or starting a combined oral contraceptive will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate if they continue the COC, continue the implant, or both, and to assess adverse events and bleeding patterns.

Detailed description:
The investigators will recruit women being seen in a UC Davis medical office or who contact our research office. Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit. The investigators expect that most women will be recruited while in the office who decide to initiate COCs or are continuing COC use-these women will be offered the ability to talk to research staff about the study.

Visit 1:

Informed consent will be obtained. As part of informed consent, subjects will be educated that there is little data available on the adverse effects of combined COC and ENG implant use. The consent form will include a standardized description of the side effects and bleeding profile of COCs and the implant. Subjects will also need to review the package label information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining informed consent, subjects will be screened for entry criteria. Medical history will be obtained. A urine pregnancy test will be performed. Eligible subjects will receive a prescription for the desired COC (if needed) and have a Nexplanon contraceptive implant placed. A diary will be dispensed for the subject to document daily bleeding, COC use and adverse events.

Follow-up A follow-up visit will occur at 1 month (+1 week) and 3 and 6 months (+2 weeks). The diary will be reviewed and a copy made to keep with the source documentation. Adverse events will be determined by inquiry and diary review. The subject will inform the study staff if she is using her COC and if she wants to continue use of her COC and ENG implant. At the 1 and 3 month visits, additional diaries will be dispensed as needed. The ENG implant will be removed upon request at any time during the study.

A phone call will occur approximately 1 week prior to the 3 and 6 month visits to check status and remind subject of the scheduled visit. Study participation will be complete after the 6 month follow-up visit.

No surveys will be used that the subject fills out herself. A daily diary will be used.

No blood draws will occur during this study.

Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use, and reason for using COC (contraception, medical or both).

Because women are being enrolled who are already currently using COCs or who plan to start COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a COC. We would not expect any increase in side effects by adding a contraceptive implant to COC users. Of note, the primary risk with COC use is related to the estrogen which can increase the risk of venous thromboembolic disease. The implant has no estrogen. All products being used in the study are FDA-approved for contraception.

Arms:
arm 1: Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women starting a COC or recently started a COC within the past month will be considered new starts.

Interventions: intervention 1: Etonogestrel contraceptive implant
Intervention descriptions: intervention 1: Place nexplanon

Protocol document:
Prot_SAP_000.pdf: 
PROTOCOL TITLE: Nexplanon Use in Women Primarily Choosing a Combined Oral 
Contraceptive: a Proof of Concept Trial 
Page 1 of 11 
Version 3 
 
Revised: August 12, 2016 
1) 
Protocol Title 
Title:  Nexplanon Use in Women Primarily Choosing a Combined Oral 
Contraceptive: a Proof of Concept Trial 
Protocol Version Date: August 12, 2016 
2) 
Objectives 
 
2.1.1 Primary objective: 
Evaluate the tolerability (side effects) and acceptability (continuation of the 
implant throughout the study) of concomitant etonogestrel (ENG) implant use in 
women choosing a combined oral contraceptive (COC) for contraception. 
 
2.1.2 Secondary objectives: 
Evaluate the following outcomes: 
 Demonstrate that women desiring a COC are willing to use ENG implant 
concomitantly as a continuous “back-up” contraceptive 
 Bleeding patterns while using a COC concomitantly with ENG implant  
 Continuation rate of COC over 6 months of evaluation 
 Plan to continue the COC and/or implant after the study 
 
2.1.3 Hypotheses.  
1. Women who desire a COC for contraception will be willing to use ENG 
implant concomitantly as a continuous back-up method. 
2. Women using a COC concomitantly with ENG implant will primarily 
experience regular bleeding patterns, especially after the third cycle of COC 
use. 
3. Tolerability will be good and acceptability high in women who use a COC 
concomitantly with ENG implant 
4. A high percentage of women in the study will still be using the ENG implant 
after 6 months. 
 
3) 
Background 
 
The ENG implant is a very highly effective method of contraception. The implant is 
designed to provide contraceptive efficacy for 3 years with a relatively quick return 
of fertility upon its removal. The implant and the intrauterine device comprise the 
types of long-acting reversible contraceptive (LARC) methods available throughout 
the world. Use of these methods is associated with lower rates of unintended 
pregnancy as compared to shorter acting methods or barrier methods of 
contraception (Winner 2012). 
 
In the United States, 45% of all pregnancies are unintended (Finer 2016). This latest 
rate, from 2011, is a drop from a peak of 51.0% in 2008 and lower than the rates of 
48.0% in 2001 and 49.2% in 1994 (Henshaw 1998, Finer 2014). This decline is 
potentially related to increased use of contraception, especially LARC methods 


PROTOCOL TITLE: Nexplanon Use in Women Primarily Choosing a Combined Oral 
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including the intrauterine device and the ENG implant (Kavanaugh 2015). COCs 
still make up a much greater proportion of contraceptive use by U.S. women as 
compared to LARC methods, despite the comparatively lower efficacy of COCs. 
Approximately 26% of contracepting women in the U.S. use an oral contraceptive 
and a smaller percentage use a ring or patch (Daniels 2015). COCs offer women 
more regular bleeding patterns. However, the requirement for daily use, ability to 
forget to use the product, and the current status in most parts of the U.S. for women 
to pick up a new prescription monthly at the pharmacy significantly influences the 
chance for user error. As a result, real-life use of COCs results in higher unintended 
pregnancy rates than LARC methods. 
 
Currently, among U.S. contraceptors, 10.3% use IUDs and 1.3% use implants for a 
combined LARC use rate of 11.6% (Kavanaugh 2015). The ENG implant, although 
it is much easier for a variety of healthcare providers to place than an IUD (since no 
pelvic examination is required), is underutilized as compared to IUDs. The primary 
reason appears to be related to menstrual irregularities, which also is associated 
with discontinuation or removal. The largest US trial of the ENG implant showed 
relatively high rates of frequent or prolonged bleeding (see figure). Accordingly, 
13% of subjects discontinued for bleeding irregularities within 2 years amongst US 
women (Funk). A systematic review of multiple trials found discontinuation rates 
for bleeding irregularities or amenorrhea in the US and Europe of 13.1% and 
13.6%, respectively (Mansour 2008), A recent retrospective chart review reported a 
discontinuation rate of 14.8% due to bleeding irregularities in women had a higher 
BMI (mean 28.5). Discontinuation rates due to bleeding irregularities have been 
reported to be as high as 23% in a study from the UK (Agrawal). 
 
 
Few studies have attempted to evaluate effective treatments for bleeding 
irregularities in women using the ENG implant. A recently published study 
randomized 32 women with 7 or more days of “bothersome” bleeding to 14 days of 
a COC containing EE 30 mcg and levonorgestrel 150 mcg, or placebo (Guiahi 
2015). Although the COC quickly decreased the bleeding, the bleeding returned 
within days of treatment cessation. A recently completed study by this investigator 
(Creinin), supported by Merck, showed that women who use COCs together with 


PROTOCOL TITLE: Nexplanon Use in Women Primarily Choosing a Combined Oral 
Contraceptive: a Proof of Concept Trial 
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Revised: August 12, 2016 
the implant for 28-84 days are more likely to report significant improvement in 
bothersome bleeding complaints as compared to placebo.  These studies 
demonstrate the potential for using COCs to treat bothersome bleeding that can 
occur with implant use.  For the purposes of the proposed trial, the important 
message from both of these studies is that women who use COCs with an implant 
don’t have the bothersome bleeding that can occur with implant use alone. 
 
For our society to further decrease unintended pregnancy, a continued shift of use 
toward LARC methods is needed. A gradual shift over time has occurred but there 
still remains a high proportional use of COCs. Circulating progestin levels with the 
ENG implant are significantly lower than with COCs and women using COCs with 
an ENG implant do not complain of increased adverse events based on our recent 
Merck supported trial. Accordingly, one could hypothesize that most women using 
a COC plus the ENG implant will feel simply like they are using the COC. Thus, if 
women wanting to use a COC will use the ENG implant concordantly, they will be 
using the COC they want to use while getting the significantly higher level of 
contraceptive protection afforded by the implant. The ENG implant acts as a 
continuous back-up for when the woman forgets her pill, can’t get to the pharmacy, 
or is sick and vomiting her pill. This model of “allowing” women to use the COC 
they want to use while giving them a LARC method as back-up at the same time 
has the potential to have a huge public health impact on lowering unintended 
pregnancy rates. 
 
References: 
Agrawal A, Robinson C. An assessment of the first 3 years' use of Implanon in 
Luton. J Fam Plann Reprod Health Care 2005;31:310-2. 
Casey PM, Long ME, Marnach ML, Bury JE. Bleeding related to etonogestrel 
subdermal implant in a US population. Contraception 2011 May;83:426-30.  
Daniels K, Daugherty J, Jones J, Mosher W. Current contraceptive use and 
variation by selected characteristics among women aged 15-44: United States, 
2011-2013. Natl Health Stat Report. 2015;86:1-14. 
Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United 
States, 2001-2008. Am J Public Health 2014;104:S43-8. 
Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 
2008-2011. New Engl J Med 2016;374:843-52. 
Funk S, Miller MM, Mishell DR Jr, et al. Safety and efficacy of Implanon, a 
single-rod implantable contraceptive containing etonogestrel. Contraception 
2005;71:319-26. 
Guiahi M, McBride M, Sheeder J, Teal S. Short-term treatment of bothersome 
bleeding for etonogestrel implant users using a 14-day oral contraceptive pill 
regimen: a randomized controlled trial. Obstet Gynecol 2015;126:508-13. 
Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect 
1998;30:24-9,46. 


PROTOCOL TITLE: Nexplanon Use in Women Primarily Choosing a Combined Oral 
Contraceptive: a Proof of Concept Trial 
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Revised: August 12, 2016 
Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible 
contraceptive methods among U.S. women, 2009-2012. Obstet Gynecol 
2015;126:917-27. 
Mansour D, Korver T, Marintcheve-Petrova M, et al. The effects of Implanon on 
menstrual bleeding patterns. Eur J Contracept Reprod Health Care 
2008;13(suppl):13-28. 
Weisberg E, Hickey M, Palmer D, et al. A randomized controlled trial of 
treatment options for troublesome uterine bleeding in Implanon users. Hum 
Reprod 2009;24:1852-61. 
Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, et al. 
Effectiveness of long-acting reversible contraception. New Engl J Med 
2012;366:1998-2007. 
 
4) 
Inclusion and Exclusion Criteria 
 
Inclusion Criteria: 
 
Women 16 years and older being seen in a UC Davis medical 
office or who contact our research office 
 
Women currently using COCs or intending to initiate COCs at the 
time of the office visit for contraception 
 
Women who are able to consent or, if under the age of 18, be able 
to give assent and have a parent who is able to give parental 
consent. If the minors are emancipated or otherwise do not want to 
involve their parents, the minors must consent themselves and no 
parent consent is required. 
Exclusion Criteria:  
 Women who have contraindications to using a COC or a 
contraceptive implant (Category 3 or 4 in the CDC Medical 
Eligibility Criteria [MEC])  
o Because the CDC MEC are continuously revised, we will 
refer to the most updated criteria at 
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm 
 Women who are currently participating in a clinical trial or have 
participated within the past 30 days. 
We will not be including any of the following vulnerable populations: 
 Adults unable to consent 
 Children 15 years and younger 
 Pregnant women 
 Prisoners 


PROTOCOL TITLE: Nexplanon Use in Women Primarily Choosing a Combined Oral 
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5) 
Study Timelines 
Each subject will participate for up to 6 months. 
We anticipate it will take up to 4 months to enroll 20 subjects for this study. 
Based on the timeline below, we expect to complete all analyses by September 
2017. 
STUDY EVENT 
MONTHS 
Enrollment and 6 month follow-up of subjects 
10 
Close data set 
2 
Preparation of final study report and manuscript 
3 
TOTAL time 
15 
 
6) 
Study Endpoints 
 
As a proof of concept study, the primary outcome is the tolerability (side effects) 
and acceptability (continuation of ENG implant through 6 months) of concomitant 
ENG implant use in women choosing a combined oral contraceptive (COC) for 
contraception. Continuation will be important to assess as some women may choose 
to discontinue the COC and rely on the ENG implant. 
 
Secondary outcomes will include willingness to accept concomitant ENG implant 
use with a planned COC, COC continuation rate over 6 months, bleeding patterns 
and plan to continue ENG implant after 6 months. 
 
All products being used in the study are FDA-approved for contraception.  Safety 
data will be collected in relation to severe adverse outcomes (as defined by the 
FDA). 
 
7) 
Procedures Involved 
 
We will recruit women being seen in a UC Davis medical office or who contact our 
research office.  Potential participants must be women currently using COCs or 
intending to initiate COCs at the time of the office visit. 
 “New starters”: subjects who have the implant placed four or less weeks 
after the initiation of a COC or who are prescribed the COC on the day of 
the implant initiation.   
 “Current pill users” subjects who have been using a COC for more than 
four weeks prior to implant placement.   


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Contraceptive: a Proof of Concept Trial 
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We intend to enroll approximately 10 subjects in each of the groups. We expect 
that most women will be recruited while in the office who decide to initiate COCs 
or are continuing COC use—these women will be offered the ability to talk to 
research staff about the study.   
 
Visit 1 (Screening/Enrollment): 
Informed consent will be obtained. As part of informed consent, subjects will be 
educated that there is little data available on the adverse effects of combined COC 
and ENG implant use. The consent form will include a standardized description of 
the side effects and bleeding profile of COCs and the implant. As per standard of 
care, subjects will also need to review the package label information for Nexplanon 
and sign the FDA-required Nexplanon consent. After obtaining informed consent, 
subjects will be screened for entry criteria. Medical history will be obtained. 
Eligible subjects will receive a prescription for the desired COC (if needed) and 
have a Nexplanon contraceptive implant placed. A urine pregnancy test will be 
performed prior to Nexplanon placement. The Nexplanon will be placed as 
indicated by the standard guidelines. A diary will be dispensed for the subject to 
document daily bleeding, COC use and adverse events. Subjects will be instructed 
to either start or continue their COCs, as indicated. 
 
If subjects would like to complete the screening visit separate from enrollment, an 
additional visit will be made for implant placement. Subjects will be compensated 
at the time of the implant placement for screening/enrollment. 
 
Follow-up 
A follow-up visit will occur at 1 month (+1 week) and 3 and 6 months (+2 weeks) 
after Nexplanon placement. The diary will be reviewed and a copy made to keep 
with the source documentation. At the 1- and 3-month visits, additional diaries will 
be dispensed as needed. Adverse events will be determined by inquiry and diary 
review. The subject will inform the study staff if she is using her COC and if she 
wants to continue use of her COC and ENG implant. The ENG implant will be 
removed upon request at any time during the study. All subjects will be followed 
for the full six months regardless of whether they discontinue the implant or COC.   
 
A phone call will occur approximately 1 week prior to the 3 and 6 month visits to 
check status and remind subject of the scheduled visit. Study participation will be 
complete after the 6 month follow-up visit. 
 
If a subject misses a visit, efforts will be made to have her return to the research 
office as close to the study window as possible.  She will be contacted three times 
and then sent a letter and certified letter to contact the research study office. 
 
No surveys will be used that the subject fills out herself.  A daily diary will be used. 
 
No blood draws will occur during this study. 
 


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Contraceptive: a Proof of Concept Trial 
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Revised: August 12, 2016 
Data to be collected by study staff include demographics, past medical and 
gynecologic history, prior and current contraceptive use, and reason for using COC 
(contraception, medical or both). 
 
Because we are enrolling women who are already currently using COCs or who 
plan to start COCs, the COC is not a study drug.  The study intervention (study 
drug) is the contraceptive implant.  The systemic hormone exposure with a 
contraceptive implant is minimal relative to a COC.  We would not expect any 
increase in side effects by adding a contraceptive implant to COC users.  Of note, 
the primary risk with COC use is related to the estrogen which can increase the risk 
of venous thromboembolic disease.  The implant has no estrogen. All products 
being used in the study are FDA-approved for contraception. 
 
8) 
Data and/or Specimen Management and Confidentiality 
All data will be presented descriptively. 
The sample is a convenience sample for proof of concept. A total of 20 women will 
be enrolled to evaluate if women who desire a COC method are willing to accept 
having a ENG implant placed to use along with their planned COC. 
Data that is collected will be kept in a secure and confidential manner in the 
Department of Obstetrics and Gynecology.  Only study staff will have access to 
both electronic and paper study documents. All study staff will have completed IRB 
required CITI training and University of California Davis privacy and security 
trainings, as well as study specific training. 
Subjects will be assigned a unique study specific subject number.  All data will be 
associated with that number.  No personal identifying information will be used in 
the data analysis.  Study personnel who are delegated by the Principal Investigator 
will be responsible for the transmission, receipt and management of the data. 
At University of California, Davis, the information collected for this study will be 
recorded on paper source documents.  The source documents will be kept in a 
locked file cabinet in a room with limited access.  Only study personnel will have 
access to both the room with the file cabinet and the file cabinet.  This room is 
locked at all times when study personnel are not occupying the room.  Data will be 
stored at least two years after publication.  
All data that is kept electronically will be stored on a University of California Davis 
Health System server.  Access to the servers, specific folders, and files will be 
password protected.  The use of removable media (USB drives, CD/DVD, etc.) will 
be kept to a minimum and will only have password protected files.   
The identifying information will be collected for study-contact and reimbursement 
related purposes include: name, phone number(s), email address, date of birth, 


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address, social security number and an emergency contact.  This information is 
collected at screening and updated at each contact with the subject.  Subject contact 
information will be maintained confidentially as part of the subject’s source 
documents.  No identifying information will be entered into the study data base or 
used as part of the data analysis. 
No data will be transported to an outside entity. 
9) 
Data and/or Specimen Banking 
No data or specimen will be banked for future research. 
 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
Research staff and study investigators will monitor for side effects. The research 
staff and study investigators are in the research office daily.  The research study 
staff and investigators have regularly scheduled research meetings during which 
enrollment, participant status and adherence, unexpected adverse events and study 
issues are discussed. The study investigators will review all necessary information 
and at shorter intervals when indicated. 
 
Adverse events will be reported to the study PI as they occur. Any adverse events 
that are required to be reported to the University of California, Davis IRB will be 
reported according to the IRB reporting guidelines. 
 
Safety information will be collected through subject diaries and during study visits. 
Subjects will record any adverse events on daily diaries, and they will be 
encouraged to call the research office with any questions or concerns regarding 
side effects. Study visits will occur at 1, 3 and 6 months.  
 
We will use descriptive statistics to analyze the safety data. 
 
11) Withdrawal of Subjects 
Subjects may be discontinued prematurely if: 
 If the subject withdraws consent 
 The FDA withdraws the implant from the market 
 
Subjects may withdraw their consent to participate in the study at any time. 
Subjects who choose to discontinue will be asked to return to the research office 
for a discontinuation visit. At this visit, final study visit procedures will be 
completed, including collection and review of study diaries, assessment of 


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Contraceptive: a Proof of Concept Trial 
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adverse events, and subject’s final plans for the ENG implant. If a subject refuses 
to return to the site for a discontinuation visit, the staff will request that the 
subject return her diaries using a traceable shipping method. Subjects will be 
considered lost to follow-up at the end of the study.  
 
The goal of the study is to follow all subjects for six months whether or not they 
continue one or both contraceptive methods (implant and COC).  Subjects can 
discontinue one or both methods during the study, but we would want to follow 
their outcomes through six months. 
 
12) Risks to Subjects 
The subjects will be using COCs as part of their standard of care.  Subjects who 
are under the age of 18 are at no greater risk during study participation than those 
18 and older. 
 The side effects while using an implant with the COC may be 
increased, specifically irregular menstrual bleeding and those 
associated with the progestin component of the combined oral 
contraceptive pill, which include mood changes, weight gain, acne, 
and growth of hair in areas of the face, back or chest. 
 The risks specific to the contraceptive implant placement include pain, 
bleeding, bruising, infection, scar and swelling at placement site, 
expulsion of the implant, migration of the implant within the arm or 
rarely to other locations in the body including the lungs, injury to 
nerves or blood vessels in the arm, breaking of the implant making 
removal difficult, difficulty with removal requiring surgery to remove 
the implant 
 Other common side effects may include: headache, vaginitis 
(inflammation of the vaginia), breast pain, viral infections, such as 
sore throats or flu-like symptoms, stomach pain, painful periods, 
nerviousness, depressed mood, back pain, nausea, dizziness or pain. 
 Rare, but serious side effects may include ovarian cysts, a blood clot in 
your legs or lungs, stroke, high blood pressure, gallbladder problems, 
or liver tumors (noncancerous or cancerous).  
 Should you become pregnant, the risk of ectopic pregnancy is slightly 
increased when pregnancy occurs when a contraceptive implant is in 
place.  An ectopic pregnancy is a pregnancy that grows outside of the 
uterus.  However, the likelihood of having an ectopic pregnancy is 
significantly decreased because the chance of becoming pregnant is 
very low with the implant. None of the hormones being used are 
known to increase the risk of abnormalities for a developing 
pregnancy. 


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Contraceptive: a Proof of Concept Trial 
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13) Potential Benefits to Subjects 
Participants will have a higher likelihood of preventing pregnancy because the 
implant is significantly more effective than a COC. 
 
14) Multi-Site Research 
N/A 
 
15) Community-Based Participatory Research 
N/A 
 
16) Sharing of Results with Subjects 
Results will not be shared with subjects. 
 
17) Prior Approvals 
This study was approved as an investigator-initiated grant by Merck & Co. 
 
18) Provisions to Protect the Privacy Interests of Subjects 
Participants will only interact with study personnel who are trained on the 
protocol and have completed training regarding Good Clinical Practice (GCP) 
codes and patient confidentiality. All questions that the participant has regarding 
confidentiality concerns will be addressed. Participants will be assured that their 
privacy will be vigilantly protected in accordance to local guidelines and HIPAA 
policies. Any information that is accessible to the research team will be either 
self-reported by the subject, or only accessed by the research team with explicit 
written permission from the subject. 
 
19) Compensation for Research-Related Injury 
We will use the language required by UC Davis IRB as presented in Form HRP 
502- Consent: 
It is important that you promptly tell the person in charge of the 
research if you believe that you have been injured because of taking 
part in this study. If you are injured as a result of being in this study, the 
University of California will provide necessary medical treatment. 
Depending on the circumstances, the costs of the treatment may be 
covered by University or the study sponsor or may be billed to your 


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insurance company just like other medical costs. The University and the 
study sponsor do not normally provide any other form of compensation 
for injury.  For more information about compensation, you may call the 
IRB Administration at (916) 703-9151 or email at 
IRBAdmin@ucdmc.ucdavis.edu. 
 
If the sponsor pays any of your medical expenses, we may be required 
to give the sponsor your name, date of birth, and Medicare ID or social 
security number. 
 
20) Economic Burden to Subjects 
Subjects will not be charged anything for participating in the study. 
 
21) Drugs or Devices 
Due to the nature of the study and because the study drug (Nexplanon) is 
FDA-approved, we will work with University of California Davis 
Investigational Drug Services (IDS) to store the implants in our study 
office as we have done for other studies.  We expect most women will be 
recruited from our office and will be approached at the time they are 
receiving a COC prescription.  Because the packaging is small we can 
store all 20 implant boxes and have regular visits from IDS to ensure 
compliance (as we have done with other studies). 
☐ I confirm that all investigational drugs will be received by the Investigational 
Drug Service (IDS).  The IDS will store, handle, and administer those drugs so 
that they will be used only on subjects and be used only by authorized 
investigators. 
 
☒ I confirm that all investigational devices will be labelled in accordance with 
FDA regulations and stored and dispensed in such a manner that they will be 
used only on subjects and be used only by authorized investigators.