Clinical Trial: Study to Evaluate Safety & Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
Brief Summary: The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by subject self-assessment when compared to vehicle.
Detailed Summary:
Sponsor: Warner Chilcott
Current Primary Outcome:
- Change in Intensity of Dyspareunia, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
- Change in Maturation Index [ Time Frame: Baseline and Week 12 ]Vaginal wall smear; Maturation Index = 0.2 x parabasal + 0.6 x intermediate + 1.0 x superficial
- Change in Vaginal pH [ Time Frame: Baseline and Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Vaginal and/or Vulvar Irritation/Itching, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
- Change in Dysuria (painful or difficult urination), Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
- Change in Vaginal Bleeding Associated with Sexual Activity, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
- Change in Vaginal Dryness, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
Original Secondary Outcome: Same as current
Information By: Warner Chilcott
Dates:
Date Received: April 25, 2013
Date Started: April 2013
Date Completion:
Last Updated: February 24, 2015
Last Verified: February 2015
