One of the most troubling side effects of menopause, painful sex, now has a new treatment approved last week by the US Food and Drug Administration. It’s a pill called ospemifene (Osphena), and it acts like an estrogen on vaginal tissues to make them thicker and less fragile.
A lack of estrogen during menopause causes the tissues to become dry and thin, which can make intercourse painful.
The agency based its approval on three clinical studies of 1,889 postmenopausal women with symptoms of vaginal dryness. After 12 weeks of treatment, women had a significant improvement in their symptoms compared with those who took a placebo. Common side effects include hot flashes, discharge, muscle spasms, and excessive sweating.
A yearlong safety study found few risks associated with the drug. Osphena will, however, have a boxed warning alerting women who experience vaginal bleeding to inform their doctor because it could be a sign of early endometrial cancer.
“The FDA has been very conservative when it comes to approving new drugs for women’s mid-life quality of life due to safety concerns, so it’s very exciting to see a new one approved,” Dr. Jan Shifren, director of the Vincent menopause program at Massachusetts General Hospital, said in an interview. Topical low-dose estrogen creams and suppositories are already available by prescription to treat vaginal dryness, but Osphena is the first treatment in pill form.