Prasterone Approved for Painful Intercourse Due to Menopause

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved the first product that contains the hormone DHEA (dehydroepiandrosterone) as its active ingredient. Prasterone, a once-daily vaginal insert marketed as Intrarosa, is approved to treat dyspareunia brought on by menopause.

The approval was based on several studies: two 12-week placebo-controlled trials comprising 400 healthy postmenopausal women looked at the drug's efficacy, and five trials (four 12-week placebo-controlled and one year-long open-label) established prasterone's safety. Compared with placebo, the drug was associated with reduced pain during sexual intercourse. Common side effects included abnormal Pap smear and vaginal discharge.

The FDA notes that DHEA is included in some dietary supplements, but that the efficacy of these products has not been confirmed.