CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Femring® +1 moredrug
Likely dose
Femring® 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00563576
NCT00563576N/ACompleted

Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

Columbia University·interventional·Posted Nov 26, 2007·Updated Dec 15, 2021

In Brief

A clinical study evaluating Femring® and DepoProvera ® for Metrorrhagia. Completed, enrolled 71 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetrorrhagia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 26, 2007
Enrollment StartSep 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.6 years ago

Interventions

Femring®drug

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.

DepoProvera ®drug

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.