Phase 3 Completed N=82 Randomized Triple-blind Treatment

Management of Etonogestrel Subdermal Implant-related Bleeding

ESI-related Bleeding

Source: ClinicalTrials.gov NCT01658995 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcomePrimary: Secondary Treatment — 20; 23 Participants — p=0.37

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.