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Generic: name Ospemifene
Brand name: Senshio
Formulation: 60 mg film-coated tablets
Market Authorisation holder: Shionogi B.V.
Indication: The treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for vaginal oestrogen therapy.
Dose: 60 mg once daily with food taken at the same time each day.
Cost: 28 tablets = £39.50.
Classification: Prescription only medicine (POM) subject to additional monitoring (▼)
What you need to know
Ospemifene 60 mg tablets are licensed for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in postmenopausal women who are not candidates for vaginal oestrogen therapy.
The application for marketing authorisation included data from four phase 2 and 3 studies.
Only one of the four co-primary outcome measures assessed over 12 weeks involved a clinical endpoint (reduction in severity of dyspareunia or vaginal dryness).
Ospemifene 60 mg daily produced a statistically significant modest reduction in severity of dyspareunia over placebo in both studies in which it was assessed.
Ospemifene 60 mg daily produced a statistically significant modest reduction in severity of vaginal dryness over placebo in one of the two studies in which it was assessed.
In clinical trials, ospemifene was not directly compared with other active treatments for VVA.
Common adverse effects include vulvovaginal candidiasis, hot flushes, muscle spasms, headache, rash and vaginal/genital discharge.
Uncommon adverse effects included endometrial hypertrophy and hypersensitivity reactions.
About vulvar and vaginal atrophy
Vulvovaginal atrophy (VVA) is a common condition, particularly in postmenopausal women, although it is not always symptomatic.1 2 With declining levels of oestrogen at the menopause, the vaginal epithelium thins, vaginal blood flow decreases and there is a reduction in vaginal lubrication. Other changes include alterations in the resident flora with a decrease in acid-producing bacteria and a rise in vaginal pH.2 Commonly reported symptoms include dryness, irritation of vulva, burning sensation, …
Competing interests None declared.
Provenance and peer review Written by the DTB team; externally peer reviewed.