Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
Status:
Completed
Trial end date:
2018-03-15
Target enrollment:
Participant gender:
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.