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 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.
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