Clinical Trial: A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 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%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vagi
Brief Summary: The purpose of this study is to determine the therapeutic equivalence of Mylan'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: Mylan Inc.
Current Primary Outcome:
- Vaginal Cytology [ Time Frame: Study Day 8 ]
Proportion of patients in the Per Protocol (PP) population that are identified as responders at the end of the treatment period on Study Day 8.
A responder is defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology.
- Vaginal pH [ Time Frame: Study Day 8 ]Vaginal pH ≤5.0 with change from baseline vaginal pH of at least 0.5.
Original Primary Outcome:
- Vaginal Cytology [ Time Frame: Study Day 8 ]
Proportion of patients in the Per Protocol (PP) population that are identified as responders at the end of the treatment period on Study Day 8.
A responder is defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology.
- Vaginal pH [ Time Frame: Study Day 8 ]Vaginal pH <5.0 with change from baseline vaginal pH of at least 0.5.
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: Mylan Inc.
Dates:
Date Received: July 16, 2014
Date Started: June 2014
Date Completion:
Last Updated: March 15, 2016
Last Verified: March 2016