drugset / Trial / NCT02995694

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

NCT02995694

Phase 3 Completed 535 enrolled Alvogen Pine Brook LLC
RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to determine the therapeutic equivalence of Alvogen'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
2016-03
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.01 % Other