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

Atrophic Vaginitis Clinical Trial

Official title:
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis

Clinical Trial 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.

Clinical Trial Description

This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo. Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment. Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows: - Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) - Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott) - Placebo: Test product vehicle cream (Alvogen Pine Brook LLC) Patients completed up to three clinic visits as follows: - Visit 1 - Screening: Day -14 to Day -1 - Visit 2 - Randomization: Day 1 - Visit 3 - End of Study: Day 8, maximum Day 10 Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02995694
Study type Interventional
Source Alvogen Pine Brook LLC
Contact
Status Completed
Phase Phase 3
Start date March 2016
Completion date December 2016
View Details
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