ESI-related Bleeding | Management of Etonogestrel Subdermal Implant-related Bleeding
ESI-related Bleeding research study
What is the primary objective of 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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DoxycyclineDoxycycline 100 mg oral capsules twice daily for 10 days
Drug:PlaceboPlacebo, one capsule orally twice daily for 10 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DoxycyclineDoxycycline 100 mg oral capsules, twice daily for 10 days
PlaceboPlacebo capsules, identical to oral Doxycycline 100 mg, twice daily for 10 days.
Start Date: August 2012
Completed Date: December 2017
Phase: Phase 3
Primary Outcome: Efficacy and safety of Doxycycline compared to placebo for unacceptable bleeding
Secondary Outcome: Patient Satisfaction
Study sponsors, principal investigator, and references
Principal Investigator: Petra Casey, MD
Lead Sponsor: Petra M. Casey