Medication Monitor



Generic Name (Trade Name—Company)
Notes
November 18, 2016

Prasterone

(Intrarosa—Endoceutics)
FDA approves DHEA agent to treat postmenopausal women experiencing pain during sex

FDA approved prasterone to treat women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause. It is the first FDA-approved product containing the active ingredient dehydroepiandrosterone (DHEA).

Efficacy of prasterone, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, aged 40 to 80 years, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA.

Women were randomly assigned to receive prasterone or a placebo vaginal insert. When compared twith placebo, prasterone was shown to reduce severity of pain experienced during sexual intercourse.

Its safety was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Although DHEA is included in some dietary supplements, efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating, or preventing any disease.