Management of Etonogestrel Subdermal Implant-related Bleeding
Study type: Interventional What is this?
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.
Study phase: III What is this?
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.
- 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.
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
- 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
- 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.