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

  • 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 ]

    Evaluation and comparison between treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) will be considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) will be considered a treatment failure.


    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