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Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
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.
Details
| Lead sponsor | Actavis Inc. |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 663 |
| Start date | Wed May 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Feb 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Atrophic Vaginitis
Interventions
- Generic Estradiol Vaginal Cream USP, 0.01%
- Estrace® Vaginal Cream USP, 0.01%
- Vehicle Vaginal Cream
Countries
United States