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Generic name: Prasterone.
Brand name: Intrarosa.
Formulation: 6.5 mg pessary.
Market Authorisation holder: Endoceutics Limited
Indication: The treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Dose: 6.5 mg prasterone (one pessary) administered once daily, at bedtime.
Cost: £15.94 for 28 pessaries and 6 applicators.
Classification: Prescription only medicine (POM) subject to additional monitoring (▼)
What you need to know
Prasterone 6.5 mg pessaries are licensed for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in postmenopausal women.
Prasterone is an inactive precursor steroid (dehydroepiandrosterone) that is converted into oestrogens and androgens.
The application for marketing authorisation included data from five phase 3 studies.
In clinical trials, prasterone was not directly compared with other active treatments for VVA.
Compared with placebo, prasterone 6.5 mg produced a modest but statistically significant reduction in severity of dyspareunia (primary outcome) and vaginal dryness (secondary outcome) after 12 weeks.
Adverse effects include vaginal discharge, abnormal cervical screening test results and weight fluctuation. Uncommon adverse effects include cervical or uterine polyps and benign breast mass.
About vulvar and vaginal atrophy
Vulvovaginal atrophy (VVA) is a common condition, particularly in postmenopausal women, although it is not always symptomatic.1 2 Estimates suggest that the prevalence of symptoms ranges from about 4% in early premenopausal women to 45% in the late postmenopause. Commonly reported symptoms include dryness, irritation of vulva, burning sensation, dysuria, dyspareunia and vaginal discharge.
Management options for vaginal and vulvar atrophy
National and international guidelines recommend using vaginal lubricants and moisturisers and low-dose vaginal oestrogen for postmenopausal women with symptoms of VVA.2–5 The National Institute for Health and Care Excellence guideline on the management of the menopause advises that for women in whom vaginal oestrogen does not relieve symptoms of urogenital atrophy, clinicians should consider increasing the dose after seeking advice from a healthcare professional with expertise in managing symptoms of …
Contributors DTB Team.
Competing interests None declared.
Provenance and peer review Commissioned; externally peer reviewed.