drugset / Trial / NCT02195986

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

NCT02195986

Phase 3 Completed 366 enrolled Mylan Pharmaceuticals Inc
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-06
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.01 % Other
Subject Estradiol Other / unclassified 2 g Other