"It wasn't even a conversation you wanted to get into years ago," said Huling, who treats patients at Olive Branch Family Medical Center, "because other than sending someone to a sex clinic, there wasn't much you could assist with the problem."

There is still no FDA approved testosterone drug for women with low sexual drive, also known as hypoactive sexual desire disorder (HSDD). But BioSante Pharmaceuticals is hoping to change that.  

 

Part of what might be driving the demand to address flagging sexual desire in women is the extensive use of drugs like Viagra. Advertising campaigns have helped normalize the discussion of sexual dysfunction, a topic that only a decade ago was largely relegated to the bedroom, and now postmenopausal baby boomers want to keep up with their mates. The question that remains is whether the positive results from the tests will outweigh health risks. That's what the FDA will determine before deeming LibiGel safe enough for use.

Biosante is currently in the Phase III stage of testing LibiGel, a transdermal testosterone gel made for women that, when applied to the arm once a day, slowly releases the hormone into the bloodstream. For women whose testosterone has fallen to lower than normal levels, the gel replaces what aging or the loss of ovaries has taken away.
This study will evaluate the risk of using testosterone in women by tracking a list of cardiovascular events including cardiovascular death, myocardial infarction, and stroke in women 50 years of age or older and suffering from at least one cardiovascular risk factor including hypertension and diabetes.

The company has been conducting a nationwide clinical study, called the BLOOM study which is a Phase II clinical trial. It was a double-blind, placebo-controlled trial, conducted in surgically menopausal women distressed by their low sexual desire and activity.

According to Biosante CEO Stephen Simes, test results thus far have been encouraging. Women who've been on LibiGel have reported "a higher number of satisfied sexual events (either intercourse, masturbation, or oral sex)."
The tests also track negative responses to the drug because an overabundance of testosterone can produce acne, unwanted facial hair, weight gain, and a deepening of the voice. BioSante is also trying to determine if there is an increased risk for heart attack, stroke, or hypertension when using the gel. The question they hope to resolve is whether the gel can benefit women without causing dangerous side effects.

"We're very confident the market is waiting for such a product," said Simes. "The two million prescriptions written per year for off-level testosterone says this product is needed."

Is testosterone measurable in women?
The question of testosterone's benefit versus risk to women has long been debated by physicians. While testosterone is naturally occurring in women, it appears at substantially lower levels than in men. Yet it is known to play a significant role in the hormonal balance of women. When testosterone drops, so too can sexual drive and desire. The problem is that a decrease in sexual libido can also be attributed to a host of other factors, including relationship difficulties, depression, stress, fatigue, or medications being used to treat other, unrelated medical problems. Since libido is a complex question, it's often difficult for practitioners or patients to tease out the root cause of a woman's loss of sexual desire.

Doctors do know testosterone declines by as much as 50 percent as a woman ages into her 40s. The decline continues through menopause, though it doesn't drop as significantly as estrogen, which declines dramatically during the mid-life change.
Another part of the equation, notes endocrinologist Don Martin, MD, with the University of Tennessee Health Science Center, is that testosterone levels vary from one individual to the next, which can make dosing problematic. When a woman is tested, her doctor may find her testosterone level falls within the normal range because normal is defined so broadly.

 

"I'm not a skeptic," noted Martin. "I just like to see data that tells you something. How do you measure testosterone levels? How do you know when it's normal and when it's not normal, which varies from woman to woman?"

Ultimately, doctors still don't know what constitutes an "ideal" or beneficial level of testosterone for women. So treatment often means adjusting medication dosage to find what works for each patient. Part of the problem with testosterone therapies has also been the delivery system. While testosterone shots can effectively raise hormone levels and bring positive results, the patient rides a hormonal roller coaster with an initial boost followed by a gradual decline as the testosterone begins to wane in the blood stream.

The testing of a testosterone patch, Intrinsa, found during a one-year trial of surgically menopausal women with very low or immeasurable testosterone, levels did exhibit improvements in mood, sexual function, and quality of life. But there was no change in cognitive function, researchers reported. And since trials were only done on surgically menopausal women, it is unknown how patients who still have their ovaries would respond to the drug. Ultimately, the FDA advisory committee gave Intrinsa a thumbs-down, saying "they were not pleased with the number of patients studied, the length of trials and modest benefits of the treatment." It was determined that longer-term safety data was needed, according to FSD-News.org, a Web site for women with sexual dysfunction issues.