Local doctor seeking clinical trial subjects for 'female Viagra'
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A new libido-boosting treatment called LibiGel is entering its third phase of clinical trials across the country, and, pending Food and Drug Administration approval, could be on the market in early 2011, according to LibiGel's maker, BioSante Pharmaceuticals.
The company calls it another step for equal rights.
Medical advancements for men having trouble in the bedroom have been available for years, with the impotence treatment Viagra approved by the FDA in 1998.
"It is time, after men have had products for so long, that women have an FDA-approved product," BioSante chief executive Stephen Simes said.
Frequently touted as the "female Viagra," LibiGel is a low-dose testosterone gel that is being tested to treat Hypoactive Sexual Desire Disorder, the medical term for persistently low sex drive in women.
The company is testing LibiGel only on women who have been through menopause naturally, and women who are experiencing surgical menopause as a result of having their ovaries removed.
Women rub a pea-sized dab of gel onto one of their upper arms once a day, and the testosterone is absorbed into the bloodstream, Simes said.
Why would a woman want to be dosed with what is typically characterized as a male hormone?
Because testosterone is also present in women and contributes to a woman's sex drive, said Dr. Suzanne Trupin, a Champaign physician who is recruiting local women for the LibiGel trial through her clinic, Women's Health Practice.
Women's bodies typically produce less testosterone after both natural and surgical menopause, and researchers think this falling testosterone level is a factor in some women's declining sex drive.
But it's not always the culprit, even in post-menopausal women. Doctors say other factors such as depression, some anti-depressant medications, illness, aging and relationship problems with a partner can also contribute to low sex drive.
"Testosterone may be a piece of the puzzle. I don't think it's the whole thing," Carle Clinic obstetrician/gynecologist Dr. Nancy Fay said.
When doctors think low testosterone might be a factor in a woman's lost libido, they sometimes try prescribing testosterone products made for men and adjusting the dosage for their female patients, Fay said. But she's convinced that for some women, there are other factors coming into play.
"I've supplemented people with that, and in some people it makes a big difference and in some people it doesn't," she said.
However large a role lower testosterone plays in low sex drive, BioSante contends there are many millions of women dealing with sexual dysfunction.
The company cites a study published in the Journal of the American Medical Association that found 40 percent of American women ages 57 to 85 experience some degree of low sexual desire.
Trupin said the LibiGel trial will look at both how effective and how safe the treatment is.
Participants will be screened for various health factors, but BioSante is basically looking for trial participants who are post-menopausal, who have a lower sex drive than they used to have and who find that to be a problem.
That last factor is important because low libido simply isn't a problem for everyone. There are men and women who get along just fine without a sex life, Trupin said, but for those who don't, it can cause not only problems in relationships but also stress and other health problems.
On the flip side, people with satisfying sex lives tend to sleep better and experience less depression, she said, and those who sleep better also tend to function better during their waking hours.
"For the average female, a positive sex life has many benefits," Trupin said.
BioSante, a publicly traded Illinois-based company, hopes to succeed in making a sex drug available to American women where two other drug companies haven't. Four years ago, Pfizer abandoned its efforts to prove Viagra could improve sexual function in women, and Procter & Gamble began marketing its testosterone patch for women in Europe after an FDA advisory panel rejected it based on insufficient long-term safety data.
BioSante knows there's a U.S. market for a low-dose testosterone treatment made just for women, Simes said. Last year, in this country alone, 2 million prescriptions for testosterone were written for women off-label, meaning for a use that wasn't FDA-approved, he said.
"Women, we think, are being overdosed with men's products, whereas we're testing a very low dose," he said.
Also the maker of Elestrin, a skin gel released last year to treat hot flashes in menopausal women, BioSante is encouraged by the results it has seen in earlier LibiGel trials, Simes said.
The third phase of the trial will be focused on the long-term cardio-vascular and breast safety of administering testosterone to women, a major FDA issue for approval, the company said.
Trupin said she and other researchers will watch for such potential short-term risks as acne and facial hair growth.
Fay said she thinks it would be nice to have an FDA-approved testosterone product for women that would take the guesswork out of the dosing.
But she also thinks doctors would need to carefully review a woman's history before prescribing it.
"I think there are a lot of older women with libido problems, but there are so many other factors there," she said.
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