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A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

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 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).
    • 05 Jun 2019 According to a Duchesnay media release, results were published in The Journal of The North American Menopause Society.
    • 06 Oct 2018 Results assessing the use of vulvar photography for assessment of vulvar health in women with moderate to severe vaginal dryness due to menopause, presented at the North American Menopause Society 2018 Annual Meeting
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