clinical trial · NCT03332303
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
Vulvar and Vaginal AtrophyEstrace® CreamEstradiol Vaginal CreamVehicle Cream
brief summary
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.
started
Oct 26, 2017
primary completion
Mar 15, 2018
completion
Mar 15, 2018
last updated
May 30, 2024
official title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol