Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
Status:
Completed
Trial end date:
2017-02-15
Target enrollment:
Participant gender:
Summary
The objectives of this study were to evaluate the therapeutic equivalence of the Test
formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva
Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol
vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to
demonstrate the superiority of the Test and Reference (active) treatments over Placebo
(vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test,
Reference, and Placebo treatments in participants with atrophic vaginitis.