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Efficacy and long-term safety of ospemifene in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women: A 52-week, randomized, double-blind, placebo-controlled, parallel-group study comparing 60 mg oral daily dose of ospemifene with placebo.

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Trial Profile

Efficacy and long-term safety of ospemifene in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women: A 52-week, randomized, double-blind, placebo-controlled, parallel-group study comparing 60 mg oral daily dose of ospemifene with placebo.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Sep 2022

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At a glance

  • Drugs Ospemifene (Primary)
  • Indications Atrophic vaginitis; Vulval disorders
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms 52 wks VVA study
  • Sponsors Hormos Medical; 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).
  • 06 Oct 2012 Tolerability results presented at the 23rd Annual Meeting of the North American Menopause Society.
  • 18 Apr 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT00566982).

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