Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study
Condition: Contraception
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Etonogestrel contraceptive implant
Intervention type(s): Drug
Intervention description(s): Place nexplanon
Other intervention name(s): Nexplanon
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: oral contraceptive; contraceptive implant; contraception; adherence; adverse event