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Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

NCT00563576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-12-15

Study results available
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Summary

Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.

Conditions

  • Metrorrhagia

Interventions

DRUG

Femring®

Estrogen vaginal ring (100 mcg) placed for the first 90 days of Depo-Provera use. Femring® (estradiol acetate vaginal ring) is a flexible off-white ring designed for vaginal insertion with measurements that include an outer diameter of 56 mm, cross-sectional diameter of 7.6 mm, and core diameter of 2 mm. Femring® 0.1 mg/day has a central core containing 24.8 mg of estradiol acetate which releases at a rate equivalent to 0.1 mg of estradiol per day for 3 months.

DRUG

DepoProvera ®

Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. It is usually given once every 3 months (13 weeks), and the recommended dose is 150 mg.

Sponsors & Collaborators

Principal Investigators

  • Angela R Dempsey, MD, MPH · Medical University of South Carolina

  • Carolyn Westhoff, MD, MSc · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00563576 on ClinicalTrials.gov