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Osphena Approved to Treat Painful Sex

The U.S. Food and Drug Administration (FDA) has approved the use of Osphena (ospemifene) to treat painful intercourse in post-menopausal women.

Many women experience painful sex after menopause because the decline in the hormone estrogen causes vaginal changes. Normally, estrogen helps keep vaginal tissues thicker, wetter, and more flexible. However, when estrogen levels fall at menopause, the vagina can become thinner and brittle, making sex uncomfortable.

Hormone replacement therapy is one treatment option, but not all women can take estrogen.

The medication in Osphena acts like estrogen to keep vaginal tissues healthy, which should reduce pain with intercourse.

Osphena was tested in three clinical trials involving almost 1,900 women who had vaginal problems due to menopause. In these trials, some women were randomly assigned to take Osphena; others took a placebo. After twelve weeks, the women taking Osphena had a statistically significant improvement in their condition compared to women taking the placebo.

However, the FDA has issued a “boxed warning” for Osphena. Because the drug acts like estrogen, it can also cause the lining of the uterus (endometrium) to thicken. For women who are menstruating, this is normal. But for women who have gone through menopause, it is not. Women who have unusual bleeding while taking Osphena should see their doctor because this could be a sign of endometrial cancer.

Strokes and blood clots are other concerns mentioned in the boxed warning.

Hot flashes, vaginal discharge, muscle spasms, and increased sweating are common side effects of Osphena, but they are usually not serious.

Women should not take Osphena if they have unusual vaginal bleeding or if they are pregnant. They also shouldn’t take it if they have certain types of cancer or blood clots (or a past history of either). Women who have had a stroke or heart attack should avoid Osphena, too.

Osphena was approved by the FDA in February and may be available in the United States in June, according to a report by the Los Angeles Times. The typical dose is one pill daily with food.

Women are advised to read the instructions for Osphena carefully and consult a doctor with any questions.


Sagon, Candy

“New Drug for Painful Sex in Older Women”

(March 1, 2013)

American Family Physician

O’Connor, Nina R., MD

“Drug Warnings: Is My Medicine Safe?”

(February 2010)

Los Angeles Times

Healy, Melissa

“FDA approves a pill for post-menopausal sex problems”

(February 26, 2013)

Mayo Clinic

“Stroke – Causes”

(July 3, 2012)


“Deep venous thrombosis”

(Updated: February 19, 2012)

Sexual Medicine Society of North America

“Sex Health and Aging for Women”

U.S. Food and Drug Administration

“FDA approves Osphena for postmenopausal women experiencing pain during sex”

(New release. February 26, 2013)