U.Va. Holds Clinical Trials for Testosterone-Laden Cream, LibiGel

January 16, 2008 — A new drug designed to increase sexual desire in women who suffer from hypoactive sexual desire disorder is undergoing clinical trials at the University of Virginia Medical Center.

Anita Clayton, professor of psychiatry and author of "Satisfaction: Women, Sex and the Quest for Intimacy," says that it is too early to predict how the tests of LibiGel, a testosterone-laden cream, will turn out.

But Clayton said that it is important to recognize the importance of developing a product for women who have sexual complaints.

"We have had products for men for awhile addressing their most common complaint, which is erectile dysfunction," Clayton said. "We need to have something available for women so that we're not just talking about it, we're doing something about it."

Clayton noted that there have been studies in the past that have looked at administration of other forms of testosterone, including a patch and injections, to women with reduced sexual desire. Some of these women did experience improvements, she said, but the treatments were either not studied systematically or may have raised long-term safety concerns.

One of the benefits of LibiGel, Clayton said, is that the product's dosage is predetermined.

Clayton said that problems or complaints about sexual functioning affect a lot of women over the course of their lives.

"A third of all women have a complaint of low desire," she said. "However, when you start to look at women who have diminished desire and personal distress about it, those numbers are quite a bit lower and probably closer to about 10 percent in the U.S. population."

Distress is often determined by the relationship with a partner, Clayton said.

"Younger women may be more likely to be more distressed, but older women may be more likely to have a decline in desire," she said. "Currently, the diagnostic criteria require both decline in desire and personal distress about it to be considered hypoactive sexual desire disorder, or HSDD."

Although there's not a typical age for HSDD, Clayton said that she generally sees women who are in a partnered relationship who have had higher levels of sexual desire in the past and have had satisfactory sexual experiences with their current partners, but then experience a decline in desire.

"This tends to have an impact on the overall relationship," she said. "It impacts on the woman's perception of the level of intimacy. But it also impacts on the partner. The partner thinks, 'You don't love me, you don't desire me.' And it really isn't about that. Women try to explain, but it's difficult to adequately communicate the problem to their partners. It's a very common story."

The clinical trial for LibiGel is testing both the drug's safety and efficacy. Illinois-based BioSante Pharmaceuticals Inc. is hoping for FDA approval of LibiGel.