Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive
Women currently using or starting a combined oral contraceptive (COC) will be offered study
 enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12
 months to evaluate if they continue the implant, the COC, or both, and to assess bleeding
 patterns and adverse events.
This study will be conducted at three sites across the United States: University of
 California, Davis, University of Colorado and University of Pennsylvania. Investigators will
 recruit women currently using COCs or intending to initiate COCs for pregnancy prevention.
 Each site will recruit approximately 40 women for a total of 120 subjects.

 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 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:

 Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit
 scheduled at 52 weeks.

 At each follow up contact, the diary will be reviewed. 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.

 Study participation will be complete after the 52 week (~ 12 month) exit visit.

 No blood draws will occur during this study.

 A diary will be used but no surveys will be used.

 Data to be collected by study staff include demographics, past medical and gynecologic
 history, prior and current contraceptive use.

 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. The investigators do 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.
Inclusion Criteria:

 -  Women 18 years and older currently using COCs or who have a COC prescription and are
 intending to initiate COCs for contraception

 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])

 -  Because the CDC MEC are continuously revised, the most updated criteria will be used
 (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.

 -  Less than 2 weeks from the end of a pregnancy.