Clinical Trial: A Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%) to Estrace® Cream (0.01%) in Postmenopausal Females With Atrophic Vaginitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Alvogen Pine Brook LLC

Current Primary Outcome: Vaginal Cytology [ Time Frame: Day 8 ]

Proportion of patients in PP population identified as responders at end of the study.


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient self-assessment of the symptoms of vulvar and vaginal atrophy [ Time Frame: Day 8 ]

Evaluation and comparison between treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom.


Original Secondary Outcome: Same as current

Information By: Alvogen Pine Brook LLC

Dates:
Date Received: December 14, 2016
Date Started: April 2016
Date Completion:
Last Updated: December 15, 2016
Last Verified: December 2016