NCT02195986

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Conditions

• Atrophic Vaginitis

Interventions

Type	Name	Description
DRUG	Estradiol Vaginal Cream, 0.01%	Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)
DRUG	Estrace® 0.01% cream	Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days)
DRUG	Placebo Vaginal Cream	Placebo Vaginal Cream ( 1 x 2 g for 7 days)

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-07-21
• Last updated: 2022-03-09
• Results posted: 2017-09-06

Locations

21 sites across 1 country: United States