Just over a year ago, the US Food and Drug Administration (FDA) approved a new drug to address dyspareunia, painful intercourse caused by the loss of estrogen during menopause. As we’ve said (often), our vaginal tissues become thin, dry, and fragile as our estrogen levels decline, which can make sex very uncomfortable. Dyspareunia is common, and it doesn’t get better on its own.
Until now, treatment options have included using moisturizers (regularly) and lubricants (before sex) or replacing estrogen, either topically in the vagina or through hormone replacement therapy. Now there’s a pill that you take once a day, and I’ve had a year to see how it works for women in my practice.
For some women, it’s very effective, even within four weeks. It seems to be tolerated by most, although it can increase hot flashes for a few (especially for those still having hot flashes; more rarely in women who hadn’t been having them already). And taking a daily, oral medication seems to make for better “compliance” (actually following through) than other options that require application two times a week.
In a pre-approval 12-week Osphena trial of almost 2,000 women here in the US, the researchers saw a “statistically significant improvement” in the pain level of the women who took it compared with a control group.
Osphena is called a “selective estrogen receptor modulator,” or SERM. Although it’s not a hormone, it works like one in that it affects some estrogen-sensitive tissues, like the vagina and the uterine lining (the endometrium). The vagina will thicken and become less fragile while other tissues, such as the breast, are affected very little.
Of course, there’s no free lunch when it comes to pharmaceuticals. Some common and less-serious side effects include the aforementioned hot flashes, vaginal discharge, muscle spasms, and sweating. But a few rare and more serious side effects include blood clots, stroke, and vaginal bleeding that can indicate cancer of the endometrium.
That’s why the drug comes with a black box warning from the FDA, and why the FDA advises taking it in the smallest amounts and for the shortest time possible (it’s the same “class labeling” that also appears on localized estrogen). Dyspareunia will recur when the medication is discontinued, which is true for other treatment options, too.
We’re all awaiting the data from further studies, but biochemistry and animal studies suggest that other SERMs have reduced breast cancer incidence (think Tamoxifen) and reduced osteoporosis (Evista). This means that for some, long-term use might be beneficial in spite of the scary black box.
Osphena still isn’t the magic bullet for all menopausal ailments, but it’s helpful to have another option for treatment. In the short-term, it could provide relief for the woman who can’t put anything in her vagina—or thinks she can’t because of the pain she’s experienced. With a comprehensive treatment plan, her renewed sex life will help rejuvenate the vagina because sex, in case you forgot, “is beneficial for maintaining vaginal health,” says Dr. David Portman, lead researcher in the Osphena trials for safety and effectiveness.