A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Phase 3 Completed 622 enrolled Duramed Research

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2006-08
Primary completion: 2007-09
Completion: 2007-09

Outcome

Met primary endpoint

paper A statistically significant increase in the maturation index PMID 19252451 ↗

paper significant decreases in pH and severity of the MBS were observed for those treated with SCE-A vaginal cream compared with placebo. PMID 19252451 ↗

Publications

Results Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DR-2041	Unknown	1 g	Other
Subject	DR-2041	Unknown	2 g	Other