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Review
▼Ospemifene for vulvar and vaginal atrophy

https://doi.org/10.1136/dtb.2019.000011

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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, …

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    Footnotes

    • Competing interests None declared.

    • Provenance and peer review Written by the DTB team; externally peer reviewed.