Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-19 Sharon Snider: 301-827-6242
May 3, 2000
Consumer Inquiries:800-INFOFDA
FDA recently cleared for marketing a new medical device to aid in female sexual arousal disorder (FSAD).
The product is the Eros Clitoral Therapy Device, manufactured by UroMetrics, Inc., of St. Paul, Minn. It is available by prescription only.
The device consists of a small, soft, plastic vacuum cup that is placed over the clitoris immediately before sex and a palm-sized battery-operated vacuum pump. When activated, the vacuum pump draws blood into the clitoris, causing engorgement, which helps aid sexual arousal.
Clearance of the device was based on a review of safety and effectiveness data submitted by the manufacturer.
Urometrics studied the device in 25 women, each of whom used it at home during six sexual encounters. Fifteen of the women had FSAD and 10 did not.
The study tested for sensation, ability to achieve orgasm, sexual satisfaction and lubrication. Results showed that it improved sexual arousal in many of the women with FSAD and some of the women without FSAD. But some women in each group experienced no change.
Of the 15 women with FSAD who were treated, all 15 experienced more sensation; 7 more orgasm; 12 more satisfaction; and 11 more lubrication.
Of the 10 women with normal sexual functioning, 4 experienced more sensation; 4 more orgasm; 2 more satisfaction; and 3 more lubrication.
The device was shown to present a low risk of side effects. The women studied did not experience any adverse events from use of the product.
FSAD is a persistent or recurrent inability to attain or maintain adequate vaginal lubrication, expansion of the vagina and swelling of the external genitalia during sexual activity.
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