Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women.

Trial Profile

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2015

At a glance

  • Drugs Ospemifene (Primary)
  • Indications Atrophic vaginitis; Dyspareunia
  • Focus Registrational; Therapeutic Use
  • Sponsors Shionogi
  • Most Recent Events

    • 16 Jun 2013 Sexual function results presented at the 95th Annual Meeting of the Endocrine Society.
    • 24 Sep 2011 Results for patients with the most bothersome symptom of dyspareunia presented at the 22nd Annual Meeting of the North American Menopause Society.
    • 05 Feb 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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