Testosterone Patch for Female Sex Drive?

In women with female sexual dysfunction, testosterone doesn't help

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Before we begin, I want to stress that for those interested in the whole story of the treatment of female sexual disorder, this article about the testosterone patch should be read within the context of two other articles that I've written: Viagra for women and new--yet unapproved--female sex pill flibanserin. More specifically, the testosterone patch represents the intermediate installment of this female sexual dysfunction trilogy: an approach tried after Pfizer stopped pushing Viagra for women and before the development of flibanserin, a female sex drug that mediates neurotransmitter levels.

The quintessence of all attempts at treatment for female sexual dysfunction traces back to a 1999 article published in JAMA which is commonly referred to as the "43-31" study. The researchers from this study suggest that more than 4 out of 10 women (43 percent) have sexual problems as compared with 31 percent of men. This study laid out what continues to be the rub in every debate over treatment of female sexual dysfunction; the rub that pits pharmaceutical companies and many sexual specialists on one side, and critics claiming that pathologizing the sexual condition as yet another example of "disease mongering" on the other side.

On June 21, 2004, Proctor & Gamble applied for FDA approval of its new transdermal testosterone system (jargonese for testosterone patch), Intrinsa. Intrinsa was intended as:

Treatment of hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy. Hypoactive sexual desire disorder (HSDD) is the persistent or recurrent deficiency or absence of sexual thoughts, fantasies, and/or desire for or receptivity for sexual activity, which causes personal distress or interpersonal difficulties. Low sexual desire may be associated with low sexual activity, sexual arousal problems or orgasm difficulty.

As noted in my past coverage of female sexual dysfunction, HSDD is an antiquated term. Nowadays, the DSM-5 speaks of "female sexual arousal/interest disorder" which combines problems of desire and arousal into one clinical entity.

Results from P&G's Phase 3 clinical trials suggest that in women with 2 to 3 sexually rewarding events per month, administration of 300 µg (but neither 150 µg nor 450 µg) was linked to one additional sexually satisfying event per month.

For 2 outright reasons, the FDA refused to approve Intrinsa. First, these results are clinically meaningless. In people already having regular and satisfying sex, a testosterone patch increases the number of sexually satisfying events by one per month! Second, for this mere one extra satisfying sexual event, women with surgical menopause who are already taking estrogen would be exposed to another potentially dangerous hormone, testosterone. Let me explain.

Around the time that P&G applied for approval of its testosterone patch, everybody was freaking out about results rolling in from the Women's Health Initiative studies examining hormone supplementation.  At the time, results from these studies suggested administration of estrogen and progesterone to women post-hysterectomy increased risk of cerebrovascular events (think stroke), cardiovascular events and breast cancer. The FDA concluded that without further long-term study, it's potentially dangerous to give postmenopausal women testosterone and other hormones.

Of note, P&G's original study evaluated testosterone supplementation in participants for 52 weeks at most.

In light of the FDA's rebuff, P&G saw the futility of pushing the issue and dropped Intrinsa. In retrospect, it's obvious that P&G hoped that physicians would prescribe the testosterone patch for off-label use--specifically, in women other than those who had experienced post-surgery menopause. With lack of long-term study, however, the FDA was obviously dismayed by this possibility.

There are other research findings that also question the potential efficacy of testosterone as an intervention in people with female sexual arousal/interest disorder. First, we don't have evidence of low androgen activity in women with sexual dysfunction. Second, although we can measure intracrine or intracellular testosterone levels, we can't measure testosterone levels in the central nervous system.  Testosterone levels in the central nervous system probably have most effect on arousal and desire. In other words, we have no idea whether testosterone levels in the brain and spinal cord of those with female sexual dysfunction is deficient enough to need exogenous testosterone supplementation to begin with. Third, even in testosterone gels and patches that have been made to treat men, we have no idea how much testosterone actually gets absorbed thus making the practice of testosterone supplementation even more concerning.

But here's the thing. For many women, access to testosterone in some form is feasible. For example, women with female sexual arousal/interest disorder can still be prescribed testosterone gels and patches off label (taking men's medication). Testosterone supplements also come in naturopathic forms which can be purchased over the Internet. Finally, in other countries, testosterone is sometimes given to women with female sexual dysfunction.

So all in all, there are still ways to get your hands on testosterone to treat female sexual dysfunction; however, given what we know, it's probably a good idea to steer clear of the stuff. Research shows no real clinical benefit of testosterone supplementation in women with female sexual dysfunction, plus we don't even know if testosterone levels are deficient in women with sexual dysfunction in the first place.  And, of course, testosterone is a hormone, and hormones have been known to have potential adverse effects like stroke, blood clots, cancer and so forth.

Selected Sources

Article titled "Testosterone therapy for reduced libido in women" by R Basson published in Therapeutic Advances in Endocrinology and Metabolism published in 2010.  Accessed on 3/13/2015.

Article titled "The Pinking of Viagra Culture: Drug Industry Efforts to Create and Repackage Sex Drugs for Women" by Heather Hartley published in Sexualities in 2006.  Accessed on 3/15/2015.

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