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Management of Etonogestrel Subdermal Implant-related Bleeding

NCT01658995 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-01-26

Study results available
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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.

Conditions

  • ESI-related Bleeding

Interventions

DRUG

Doxycycline

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Petra M. Casey

    lead OTHER

Principal Investigators

  • Petra Casey, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
51 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-13
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658995 on ClinicalTrials.gov