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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2022

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At a glance

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

Most Recent Events

  • 14 Feb 2022 According to a Duchesnay media release, based on data from four clinical trial (15-50310, 15-50821, 1517I0231, 15-50718) the Health Canada has approved Osphena (ospemifene tablets) for use in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).
  • 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.

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