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FDA Approves First Female Sexual Dysfunction Device


WebMD Health News

May 3, 2000 (Washington) -- Many women may have yet another reason to rejoice. The FDA said Wednesday that it has approved UroMetrics Inc.'s Eros-CTD, the first treatment for female sexual dysfunction. The announcement follows recent reports from a urology meeting, indicating that the blockbuster male impotence drug Viagra also may perhaps offer some measure of sexual satisfaction for women.

But unlike Viagra, for which physicians already are offering some prescriptions, the Eros Clitoral Therapy Device has no potential side effects. In fact, the FDA approved the device under less stringent requirements than those usually applied to novel devices, because there were no side effects reported in the supporting study or any side effects suspected by the FDA reviewers, Sharon Stone, a FDA spokeswoman, tells WebMD.

The device is a small, soft, plastic cup that with a battery-operated pump increases blood flow to the vaginal area.

The approval was based upon a single study of 25 women, including 15 who had sexual dysfunction and 10 who did not; the 25 women used the device at home during six sexual encounters. The study tested for sensation, ability to achieve orgasm, sexual satisfaction, and lubrication.

According to the FDA analysis, all 15 women with sexual dysfunction experienced more sensation. Of those 15 women, seven also experienced more orgasms, 12 had more satisfaction, and 11 experienced more lubrication. The 10 women with normal sexual function all experienced more sensation; four also had more orgasms, two had more satisfaction, and three had more lubrication.

The concept also has been successfully applied in males, says Irwin Goldstein, MD, professor of urology at Boston University School of Medicine and one of the investigators. But further data are needed to determine its overall value for women, including whether increased blood flow makes a difference and how much vaginal lubrication actually is achieved, he tells WebMD.

In the meantime, Goldstein says, the class of patients most likely to benefit from this device appears to be women with sexual dysfunction who are interested in sex but unable to have orgasm. Pre-menopausal women with normal sexual functions are unlikely to see much of an advantage, he adds.

The device does appear to work much like Viagra, suggesting that it should have perhaps a similar effect, Ira Sharlip, MD, a urologist and partner at Pan Pacific Urology in San Francisco, tells WebMD. Viagra also appears to increase vaginal blood flow. Taken in context, Eros represents another treatment option, Sharlip says. But that is not to say that Eros is for everyone, he adds. Some men are highly resistant to using the penile pump used for impotence, and it is likely that some women also may find the concept disturbing. "I would leave it up to the patient's discretion," he tells WebMD.

Women with sexual dysfunction who would like to give it a try will be able to get one immediately, UroMetrics' spokeswoman Marlene Wesen tells WebMD. The prescription device is already available in Australia, France, and United Kingdom and will be sold in the U.S. for $359, she says.

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