Management of Etonogestrel Subdermal Implant-related Bleeding

NCT ID: NCT01658995

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-13
• Study Completion Date: 2019-12-30

Brief 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.

Detailed Description

ESI is a long-acting reversible contraceptive. Though safety and efficacy have been established world wide, only about 1 % of women have been reported to use this method. Its use is limited by bleeding pattern changes which result in requests for early removal, most commonly within the first 8 months of use.

Women ages 18-51 years, choosing ESI and who meet eligibility criteria, will be offered enrollment in the study at the time of ESI insertion. Every effort will be made to insert Implanon on the same day as consent unless medically contraindicated. Prospective diaries will be completed starting on the date of ESI insertion. All participants will be contacted by study personnel 13 weeks after enrollment and queried as to the presence of unacceptable bleeding. Bleeding concerns will be objectively assessed using a modification of the Pictorial Blood Loss Assessment Chart (PBLAC).

Participants initiating contact with bleeding concerns at any time after 13 weeks post-ESI insertion will be offered treatment randomization at the time of contact. The basis for randomized treatment will be whether the bleeding is considered "unacceptable" to the participant. This is inherently subjective, but constitutes the basis for most removal requests. Participants that report unacceptable bleeding at 13 weeks post-ESI insertion, and those who call with bleeding concerns anytime after 13 weeks post-ESI insertion, will be randomized into one of two groups, Doxycycline or matching placebo.

Participants that do not report unacceptable bleeding will continue to complete diaries and may be eligible for randomized treatment if unacceptable bleeding develops.

Conditions

ESI-related Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Post ESI implant - Doxycycline

Subjects will be randomized into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days, subsequent treatment can requested by the subjects

Group Type: ACTIVE_COMPARATOR

Doxycycline

Intervention Type: DRUG

Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Post ESI implant - Placebo

Subjects will be randomized into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days, subsequent treatment can requested by the subjects

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Interventions

Doxycycline

Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Intervention Type: DRUG

Placebo

Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Intervention Type: DRUG

Other Intervention Names

Adoxa, Alodox, Avidoxy, Bio-Tab, Doryx, Doxy Lemmon, Doxy-Caps, Monodox, Morgidox, Ocudox, Oracea, Oraxyl, Periostat, Vibra-Tabs, Vibramycin; Sugar pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Petra M. Casey

OTHER

Sponsor Role: lead

Responsible Party

Petra M. Casey

Associate Professor of Obstetrics - Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Petra Casey, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

11-008933

Identifier Type: -

Identifier Source: org_study_id