Viagra for women? It might not be too far off.
or the past 10 years, men have boosted their sex lives with Viagra.
But how far off is a magic drug for women whose libidos have fizzled out?
It may be coming soon, say the makers of a new medication aimed at kick-starting a woman’s sex drive.
LibiGel, a testosterone gel produced by BioSante Pharmaceuticals, is currently undergoing Phase 3 clinical trials in medical centers across the country, including The Medical Center for Female Sexuality in Purchase.
Women who are testing the gel, which is rubbed into the skin on the upper arm, have all gone through menopause, either surgically or naturally, and have experienced a decline in sex drive.
According to a study reported in July in the Archives of Internal Medicine, low sex drive - called hypoactive sexual desire disorder - is highest among surgically menopausal women. Women who go through menopause naturally also report a lower libido than women who are premenopausal.
Levels of testosterone do decrease as women age, says Dr. James A. Simon, medical director of the Women’s Health Research Center in Laurel, Md., where he’s been studying the connection between testosterone and sex drive for the past 15 years.
The problem, he adds, is drawing a definitive link between low testosterone and low libido. There have also been ongoing safety concerns about testosterone supplements for women.
Yet Simon, who’s also taking part in the LibiGel trials, is one of many doctors who have long advocated off-label use of testosterone cream for certain women with low sex drives.
Although Dr. Michael Werner, medical director of the center in Purchase, says he’s not able to comment on the hormone’s effect on patients currently enrolled in the LibiGel trials, he’s also been a longtime supporter of testosterone therapy for women with low libido - especially those whose blood tests reveal low levels of certain hormones.
“It’s very hard for a woman to have a good libido if her testosterone is low and her estrogen is low,” says Werner, a urologist who specializes in sexual dysfunction.
Some of Werner’s patients with low libido are treated with a low-dose testosterone cream along with other androgens including dehydroepiandrosterone, or DHEA.
Gail, a long-married patient from New Jersey, was 52 when she had a hysterectomy - including removal of her ovaries - and despaired as her sex drive plummeted. Doctors ascribed her low libido to stress until she ended up at The Medical Center for Female Sexuality.
“It took about a year to adjust all my meds, but I’ve been fine now for three years. I feel like I’m 30 again,” says Gail, who’s now 66, and currently uses DHEA, testosterone cream and estrogen.
But using hormones as a cure-all for low sex drive enrages activists like Dr. Leonore Tiefer, clinical associate professor of psychiatry at New York University School of Medicine.
About eight years ago, Tiefer founded an organization called the New View Campaign, which challenges the “medicalization” of women’s sexual issues. “There’s no correlation between testosterone levels and sexual problems. I don’t care whether they go down,” says Tiefer, a psychologist. “Hair color changes, but it doesn’t correlate with life happiness. It may be something that happens, but there’s no correlation to sexual satisfaction, sexual complaints, so what’s the point? Do you want to treat every physical change that’s associated with maturity?”
Tiefer remains opposed to any form of testosterone supplementation for women - including Procter & Gamble’s testosterone patch, Intrinsa, which the U.S. Food and Drug Administration failed to approve, citing inadequate studies on safety. (The patch has been available in the United Kingdom since 2007 for women who have gone through surgical menopause.)
“Our position is that nothing has changed since the FDA rejected Intrinsa in 2004,” says Tiefer. “Women are putting themselves in jeopardy by using this dangerous medication.”
Despite differences of opinion on testosterone therapy, doctors agree it can be difficult proving low testosterone is the sole culprit in a couple’s poor sex life.
“We have many women who function sexually perfectly normally with no male hormones, no androgen, no testosterone. On the other hand, if we’re looking at averages, the majority of women who have low or very low testosterone levels have a decrease in their interest in sex … and for them, giving them testosterone is a godsend,” says Simon, who’s also professor of obstetrics and gynecology at George Washington University School of Medicine and former president of the North American Menopause Society.
“But I could tell you it won’t help a lousy marriage.”
In fact, doctors are quick to point out that when it comes to women and libido, testosterone is only part of the equation.
Women who come to The Medical Center for Female Sexuality in Purchase are evaluated by two female staffers: sex therapist/psychologist Bat Sheva Marcus and nurse practitioner Melissa Ferrara. Werner goes over blood work and medical records but does not examine female patients.
“I do think women’s libido and sexuality are generally much more complicated than men’s, and I treat both,” says Werner. The majority of men he sees have no trouble with their libidos, he adds, and for them a drug like Viagra generally does the trick.
Women, on the other hand, are more complex and may be prescribed a variety of treatments for low sex drive, including counseling.
Dr. Lila Nachtigall, professor of obstetrics and gynecology at New York University School of Medicine, likes to study every aspect of a woman’s lifestyle before turning to testosterone.
“Libido is so complicated,” says Nachtigall, a reproductive endocrinologist. “If you have to get up early in the morning, you’re working very hard, you go to bed late, you had an argument with your partner, all those things interfere. Everything makes a difference, much more with women.”
Sometimes, she says, testosterone can help.
Nachtigall, who participated in clinical trials of Intrinsa, says she was surprised when the FDA shot it down.
“We really had no complications at all, and women loved it so much,” she says. “It seemed to make a difference at a nice, low dose.”
In the case of LibiGel, Simon is reassured to see that long-term safety is being addressed in the current study, and that women using the testosterone gel will be followed for five years. But he believes that if given at “replacement” doses that mimic levels women have in their youth, results look promising.
Even if LibiGel does eventually make it to market, testosterone supplementation is not for everyone, says Werner. “Women who have had estrogen-sensitive breast cancer, the feeling is that they should not be on testosterone because you get conversion of testosterone to estrogen,” he says.
Testosterone can also lead to an increase in bad cholesterol, or LDL, adds Werner, which, if not treated with cholesterol-lowering drugs, could potentially lead to “increased vascular events,” like heart attacks or strokes.
As far as testing LibiGel’s safety, Simon points out that women’s fears about hormones - and the FDA’s warnings about hormone-replacement therapy - have led many women to stay away from certain clinical trials.
That means it may take longer to accumulate safety data on testosterone therapy.
But for patients like Gail, there’s no denying testosterone’s impact on life in the bedroom - and no going back to the dark days of never being in the mood.
“People think sex isn’t important for older women, but let me tell you, it’s just as important as when I was 25,” she says.
