NCT01779947

Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo

An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 519 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.

Conditions

• Atrophic Vaginitis Due to Menopause

Interventions

Type	Name	Description
DRUG	Estradiol Vaginal Tablets 10 mcg
DRUG	placebo

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2013-01-30
• Last updated: 2014-06-26

Locations

25 sites across 1 country: United States