Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms

Phase 3 Completed 431 enrolled BioSante Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.

Timeline

Start: 2003-09
Primary completion: —
Completion: 2005-04

Publications

Simon JA, Bouchard C, Waldbaum A, Utian W, Zborowski J, Snabes MC. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):588-96. doi: 10.1097/01.AOG.0000254160.62588.41.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	0.87 g	—
Subject	Estradiol	Other / unclassified	1.7 g	—
Subject	Estradiol	Other / unclassified	2.6 g	—

Indications

No indication recorded.