Testosterone for women: The real story
In 1996 Pfizer, a large pharmaceutical company, filed a patent for Viagra in the United States. In March 1998 the FDA approved the drug to treat men with erectile dysfunction. It became an instant hit.
In 2004, Procter & Gamble approached the FDA to get approval of testosterone for women delivered via a patch. Their drug, called Intrinsa, was designed for hypoactive sexual desire disorder (HSDD) for women who have had their ovaries surgically removed. The patch had been studied and was found to improve symptoms in women with low sexual activity, positive sexual arousal, and orgasm difficulties.
The FDA unanimously denied the approval of testosterone for women. Many of the members believed that HSDD and treatment was not clinically meaningful. They also felt there was a lack of long-term safety data, particularly in regards to breast cancer and heart disease.
Prior to the FDA denial, numerous studies had been done showing that testosterone is both protective against cardiovascular disease and breast cancer. But in 2004, a very large study called the Women’s Health Initiative Trial showed certain synthetic hormone drugs raised the risk of those diseases. Results from that study were separately found to be flawed. In fact, women receiving hormone replacement therapy, even with synthetic drugs, at menopause had a 40% reduction in the rate of heart attacks. Studies have shown that testosterone replacement in women reduced breast cancer rates by over 50%. Nonetheless, the FDA turned Intrinsa down.
To satisfy the FDA that testosterone was safe for women would’ve taken five years and an estimated $300 million. And testosterone can’t be patented, so drug companies can’t protect their investment from generic competitors. And even though there have been studies going on for years showing the safety of testosterone, the FDA requires the manufacturer to do its own, despite the fact that the drug is widely available and has a proven safety record.
Another drug called Addyi (flibanserin) was approved for HSDD in August 2015. This drug has the potential for serious side effects such as severe low blood pressure as well as loss of consciousness. These risks increase if it’s taken with alcohol. Congress had urged the FDA to approve Addyi, as there is nothing else available that the FDA would approve for female sexual desire.
If Addyi is taken daily, women typically will have sex an additional six times a year. In other words, frequency is increased to once every other month yet there is no effect on arousal, sensation or orgasm.
In 2005, the North American Menopause Society identified that postmenopausal women with decreased sexual desire are candidates for testosterone replacement therapy. They reviewed numerous scientific papers and called for doctors to start addressing this condition.
In 2006, the Endocrine Society claimed that the syndrome, hypoactive sexual desire disorder, did not exist. Testosterone (androgen) deficiency, they claimed, just did not exist. They also said is not associated with any specific signs or symptoms. And they stated — contrary to extensive evidence — that testosterone levels do not correlate to sexual behavior. Additionally, they said that testosterone replacement wasn’t even available, even though doctors had been prescribing it for years.
In 2014 the Endocrine Society reaffirmed their claim that this condition does not exist, that testosterone replacement therapy was not available, and that it does not improve aspects of women’s sexuality.
In 2014, the North American Menopause Society reversed their stance on sexuality for women and made new recommendations. They stated that the cause and effect of low testosterone and sexual dysfunction were not defined. And they suggested that physicians and healthcare practitioners evaluating women’s concerns regarding sexual desire disorder recommend “counseling and sex therapy, with a focus on modifying the sexual technique, increasing sexual novelty…”
They also recommended “treatment of the underlying depression and anxiety, and adjustment of the antidepressant medication…” They gave recommendations for various drugs to treat the anxiety and depression that cause women to lose their sex drive and have less pleasure with sex. They also stated that hypoactive sexual desire disorder no longer exists. Absolutely absurd!
The SWAN (Study of Women’s Health Across the Nation) study began in 1994 with 3,302 participants. This is done in various medical centers in the U.S. Contrary to the FDA, the Endocrine Society, and the North American Menopause Society, they did not have bias. They simply evaluated testosterone levels and compared them to questionnaires regarding masturbation, arousal, orgasm, frequency of sex and desire.
The SWAN study found that all aspects of women’s sexuality increased or improved with rising levels of testosterone and decreased with declining levels of testosterone. The only factor of sexuality not associated with testosterone levels was pain. So painful intercourse for women is caused by something other than testosterone.
The FDA, North American Menopause Society and Endocrine Society were all biased and wrong. Keep in mind that these societies and government agencies were likely influenced by things that occurred at the time. One was the finding of the Women’s Health Initiative Trial that certain synthetic hormone drugs may be risky. Later on we found out that this trial was not pertinent to women entering menopause and hormone replacement. But right about that time Procter & Gamble attempted to get testosterone approved, the FDA rejected it, and the Endocrine Society recommended against treating women with this condition.
The North American Menopause Society made their about-face right about the time that the drug Addyi was approved. If they had supported testosterone use for hypoactive sexual disorder, a year later Addyi may have not been supported by the FDA if there was a better option available.
As far as the effect of testosterone on sexuality for women, a study was published in the New England Journal of Medicine, one of the most respected medical journals, in 2000 – before both the FDA denial and the Endocrine Society’s position that testosterone does not improve women’s sexuality.
This study put women on testosterone replacement at two different doses. So there were three groups: Placebo, 150 µg (microgram) of testosterone per day, and 300 µg of testosterone per day. They found that women with the higher dose of testosterone had more sexual fantasies, were more likely to masturbate, and were more likely to engage in intercourse at least once a week. They were more positive in their well-being and less depressed in mood. They also experienced more relationship satisfaction, had more pleasure with orgasm, and were more likely to initiate sex.
Other studies have looked at testosterone levels and its effect on women’s sexuality, as well as testosterone replacement and its effects on women’s sexuality, and they’re quite consistent.
Because testosterone is already available generically, manufacturers are not going to spend a lot of money and time proving to the FDA that the product is safe. And since testosterone is available generically and not supported by a large manufacturing company, there is little public awareness about its use. Physicians are also typically very naïve about testosterone replacement therapy as they rely significantly on manufacturers to come by their offices, bring them samples, and educate them on drugs. That is not happening with testosterone.
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Dr. Charles Mok