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