No fair, cried many a woman when Viagra came out to help men keep their penises from going flaccid. While women were appreciative of a man’s ability to curtail his penis from becoming limp (or, worse, never getting it up at all), the question—where was the counterpart to help women, who were the same age, maintain their moistness?—loomed large.

Now, nearly 15 years after Viagra, the U.S. Food and Drug Administration has approved a new drug to treat postmenopausal women with what they need to enjoy better sex: lubrication. The drug,  Osphena (ospemifene), and made by Shionogi,  mimics the effects of estrogen in vaginal tissue, which can become thinner, drier and more fragile during menopause. This makes having sex more arduous, than amorous, and more painful than powerful. The pill, taken with food once a day, is designed to make vaginal tissue thicker and less fragile to reduce dyspareunia—the medical name for pain during sex.

“Dyspareunia is among the problems most frequently reported by postmenopausal women,” says Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, in an FDA news release. “Osphena provides an additional treatment option for women seeking relief.”  

Three clinical studies were done involving nearly 1,900 postmenopausal women with signs of vulvar and vaginal atrophy, or thinning and fragile vaginal tissue. The women were randomly assigned  to take either Osphena or a placebo. In the first two studies, those who took the drug for 12 weeks experienced significantly less pain during sex than the women in the placebo group. The third study confirmed the findings of the first two. Or in other words, it worked.

But there are serious concerns about the safety of this drug, as there are with many others that use any type of hormone replacement. The major issue? While Osphena appears to be perfect for helping postmenopausal women get—and stay—lubricated, by thickening the uterus’ walls, an increase in estrogen within the uterus has been proven to lead to Endometrial, or uterine, cancer. The CDC reports that Hispanic women are the third most likely group to get uterine cancer. White women are most likely to get uterine cancer, and African American women, are the mostly likely to die from it.  As a result, the FDA cautions that the duration of the drug should be prescribed on a case-by-case basis, determined by a woman and her doctor.

Additionally, according to Osphena’s box warning, the drug can increase a woman’s risk for stroke and deep vein thrombosis, or blood clot. Other possible Osphena side effects include hot flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating. Suddenly, being less moist during arousal doesn’t seem to be such a bad thing after all.

Tags: Osphena, sexual hea, women's health

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