Management of Etonogestrel Subdermal Implant-related Bleeding


  • Study type

  • Study phase

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 11-008933
    NCT ID: NCT01658995
    Sponsor Protocol Number: 11-008933

About this study

This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be conducted within the Mayo Clinic and the Mayo Clinic Health System.

The goal of the research study is to gather information to determine whether Doxycycline is effective for the treatment of unacceptable bleeding associated with the etonogestrel subdermal implant (ESI), as compared to placebo.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Premenopausal women, aged 18-51 years
  • Expressed desire for compliance-independent contraception
  • No current pregnancy or anticipated desire for childbearing within 3 years of study enrollment and Implanon insertion
  • Agreement to participate in all study related procedures and evaluations as documented by a signed informed consent

Exclusion Criteria:

  • Current or prior use of Implanon
  • Current long-term use of Doxycycline for other indications
  • Known structural uterine abnormalities such as polyp, submucosal leiomyoma
  • Prior permanent sterilization or endometrial ablation
  • Pregnancy or desire for childbearing within 3 years
  • Contraindications to or intolerance of etonogestrel
  • Allergy to or intolerance of Doxycycline
  • Inability or unwillingness to complete study related procedures and evaluations

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Petra Casey, M.D.

Open for enrollment

Contact information:

Kristi Allen R.N.


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