Medication Tested at U.Va. Proves Effective for Pre-Menopausal Women with Lack of Sexual Desire

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December 1, 2009 — Treatment options are limited for women who are living with a distressing lack of sexual desire. But that could soon change, said Dr. Anita Clayton, professor of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine.

Perhaps millions of pre-menopausal women suffer from hypoactive sexual desire disorder (HSDD), an under-treated medical condition that may put strain on relationships with their partners.

Clayton and fellow lead investigators have announced remarkable results from several nationwide clinical trials assessing flibanserin, a new non-hormonal medication that is proving to be an effective therapy for pre-menopausal women with HSDD. Findings were presented Nov. 15 at the 12th Congress of the European Society for Sexual Medicine in Lyon, France.

Trial data demonstrate that 100 milligrams of flibanserin daily increased the number of "satisfying sexual events" and sexual desire, while decreasing the distress associated with HSDD. Flibanserin is an investigational compound being developed by Boehringer Ingelheim Pharmaceuticals Inc.

"With this data, we are making exciting progress in women's sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women," Clayton said. "This is an important milestone for an under-recognized condition for which there is no FDA-approved treatment."

She said HSDD is a complex condition that can cause distress and negatively impact a woman's self-esteem.

"Women suffering from this disorder often report feelings of frustration and anxiety and view themselves as being sexually defective," Clayton said. "They worry about their lack of desire negatively affecting their relationship and their partner. But I think it's important to note that we're not talking about women who simply don't want to have sex or aren't concerned about a lack of desire. It's about the women who suffer significant mental distress from their lack of desire."

The trial involved 1,378 pre-menopausal women with HSDD, some taking the medication and some taking a placebo. All of the women were in stable, communicative, monogamous, heterosexual relationships with a sexually functioning partner for at least one year. Women ranged in age from 18 to 55 and were required to use a reliable form of contraception.

"HSDD is not a new disorder; it's been recognized in the field for more than 30 years," Clayton said. "What's new is that people are beginning to talk about it. Before, women's sexual issues were taboo subjects – even between patient and physician. Now we have the chance to open up the dialogue."