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Painful sex? Menopausal women get new treatment

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.

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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.

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.
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