A small number of Kentucky women who are distressed about their lack of sexual desire may be able to help a drug company prove that it has a woman's answer to Viagra.
A medication called LibiGel is being tested at the University of Kentucky and other places around the country on women who have had their ovaries removed or have gone through menopause.
The women also have to exhibit a lack of libido and be "distressed" about it.
"The woman has to care," said Stephen Simes, president of BioSante Pharmaceuticals, Inc., the maker of LibiGel. "Some women don't have sex very often, and they don't care."
LibiGel is the most recent attempt by pharmaceutical makers to create a cure for women who suffer from low sexual desire or hypoactive sexual desire disorder, as it is technically called.
The disorder isn't easy to define. Women who suffer from it have no desire for sex or less desire than they think they should. And they are bothered by their lack of interest.
These are women who, once they "get going," are fine, said Dr. Ken Muse, a gynecologist who is leading the study of LibiGel at UK.
The number of women who suffer from the disorder varies depending on who you ask and what study they point to. Simes says that as many as 50 percent of women have little sexual desire and are distressed by it. Others say the number is as low as 20 percent.
Still others question whether the disorder is a creation of pharmaceutical companies, which stand to make millions on a female counterpart to Viagra.
LibiGel is a testosterone-based gel that is rubbed on the arm. It increases the amount of testosterone in the blood. If the trials and FDA approval go smoothly, BioSante hopes to bring the drug to market in 2011. It will probably cost $150 a month, Simes said.
In a previous study, women who took LibiGel had an average of five more "satisfying sexual events" over a four-week period than before using the gel, Simes said. (At the proposed price, that works out to $30 per event.)
Women who received a placebo had an average increase of 1.6 events, Simes said.
In addition to receiving pills and a cream, women who participate in the current studies will report on their feelings and desire for sex.
Figuring out how much of the change in desire is due to the drug and how much is due to other factors is complicated, Muse said.
"People are distressed by this problem, and it's only human nature to report they feel better," Muse said
About two dozen women will participate in the study at UK.
LibiGel is not the first attempt for a drug to increase a woman's desire. But, so far, the complicated nature of women's sexuality has foiled drug makers.
Pfizer, the maker of Viagra, tested the drug to see whether it would work on women. But the company hasn't asked the U.S. Food and Drug Administration to approve its use in women. Procter and Gamble tried to get approval for Intrinsa, a testosterone-based patch in 2004, but the FDA denied the request, wanting additional studies.
Part of the problem for drug companies is that scientists don't know how women's desire works. For example, they know that male hormones, such as testosterone, are part of the equation.
But they don't know how much of a role they play, Muse said.
Many things influence desire, said Lisa Martinez, executive director of the Women's Sexual Health Foundation, which is based in Cincinnati.
Women might not be interested in sex because they're stressed or tired. They might need help with housework, have a bad marriage or have a fumbling partner.
"There's so many confounding things that mediate a woman's sex drive," said Jean Koehler, an assistant professor of psychiatry at the University of Louisville and a certified sex therapist.
Studies have not found a correlation between the level of testosterone in a woman's body and her desire for sex.
However, as a woman ages, her testosterone decreases, especially after menopause, whether it occurs naturally or after the removal of her ovaries.
In those women, testosterone has been shown to work. Testosterone will not help a young woman with normal testosterone, Simes said.
But a woman who has a low, but normal, level of testosterone might benefit from testosterone, said Dr. Margery Gass, a professor of gynecology at the University of Cincinnati.
Gynecologists already prescribe — off-label — testosterone or antidepressants such as Wellbutrin, to help women who haven't gone through menopause, Gass said.
"There really is a lot of mention from women about having lost all interest in sex," Gass said. "And they regret that, especially if they have a partner."