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Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

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Trial Profile

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

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
  • Focus Adverse reactions; 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).
    • 18 May 2012 Extension study results assessing endometrial safety presented at the 60th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists.
    • 01 Jun 2010 Primary endpont results (n=826) published in Menopause
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