CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 622 enrolled
Drug / intervention
DR-2041a +3 moredrug
Likely dose
Not stated in 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/NCT00361569
NCT00361569Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

Duramed Research·interventional·Posted Aug 8, 2006·Updated Apr 20, 2015

In Brief

A Phase 3 clinical trial evaluating DR-2041a, DR-2041b, and 1 other intervention for Menopause. Completed, enrolled 622 participants across 97 sites.

Detailed Summary

This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2006
Enrollment StartAug 1, 2006
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.9 years ago

Interventions

DR-2041adrug

1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

DR-2041bdrug

2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Placeboother

1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

Placeboother

2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter