Phase 3
N=82
Management of Etonogestrel Subdermal Implant-related Bleeding
ESI-related Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01658995 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Secondary Treatment — 20; 23 Participants — p=0.37
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Doxycycline (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Petra M. Casey
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Secondary Treatment |
20; 23 | 0.37 |
| SECONDARY Subject Satisfaction |
15; 17 | 0.46 |
| SECONDARY Removal of ESI |
4; 2 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT01658995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.