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
Price :
$35
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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
- 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).