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FDA Approves Drug for Sexual Pain

by Dr. Barb DePree

Ladies, we have one more tool in the belt.

Last month, the US Food and Drug Administration (FDA) approved a new drug to treat the vaginal and vulvar pain associated with loss of estrogen in older women.

That pain is called dyspareunia, and it’s caused by the changes in the vagina and genitals that occur when we lose 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.

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.

In a 12-week 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.

Of course, there’s no free lunch when it comes to pharmaceuticals. Some common and less-serious side effects include hot flashes, vaginal discharge, muscle spasms, and sweating. But a few uncommon 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 also uncertain whether the condition will reverse itself once the drug is stopped.

Despite the scary black box, I’m thinking that Osphena gives us another option. It might not be our first choice for long-term use. It still isn’t the magic bullet for all menopausal ailments.

But it might provide a little short-term boost, for example, to make a woman with severe dyspareunia more comfortable until the moisturizers or the topical estrogen kicks in. And until her renewed sex life helps 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.


  • Claire, I’m not sure what you received as an injection. It would likely be worthwhile for you to seek out a menopause care specialist. Localized hormones have proven effective with fewer side effects than oral. And yes, as a physician I do recommend the lowest-impact treatments first. For women who don’t find relief that way, though, I have been prescribing Osphena for a while without significant negative side effects and definite improvement for most women.

    Dr. Barb on

  • Thanks Dr for this information. I got so worried when sex began to be painful. I visited a GP and he increased my hormonal replacement tablet from 2 to 3mg. He gave me an injection which I’m not sure what it was for. I have not yet had sex and still wondering if the pain will still be there. Can the condition be treated through injection? I live in South Africa and not sure whether these medicines are available here.

    Claire on

  • As one who has been on the receiving end of some nasty side-effects from prescription medications, I would think the stretching and exercise routines you recently reviewed would be the preferred choice for as long as they remain effective.

    tanstaafl2 on

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