Before we start, I want to stress that for all those interested in the whole story of this treatment of female sexual dysfunction, this article about the testosterone limitation should be read within the context of two other posts that I’ve written: Viagra for women and new–yet unapproved–female sex pill flibanserin. More especially, the testosterone patch signifies the intermediate installation of this female erectile dysfunction trilogy: an approach attempted after Pfizer stopped pushing Viagra for women and prior to the development of flibanserin, a female sex medication that mediates neurotransmitter levels.
Studies on the Sexual Dysfunction of Women
The quintessence of all efforts at treatment for female sexual dysfunction hints back to a 1999 article published in JAMA which is commonly known as the”43-31″ research. The researchers from this study suggest that more than 4 out of 10 girls (43 percent) have sexual difficulties as compared with 31% of men. This research laid out what has been the rub in each discussion over the treatment of female sexual dysfunction; the rub that pits pharmaceutical companies and lots of sexual pros on one side, and critics claiming that pathologizing the sexual condition as yet another example of”disease mongering” on the opposing side.
On June 21, 2004, Proctor & Gamble applied for FDA approval of its new transdermal testosterone program (jargonese for testosterone patch), Intrinsa. Intrinsa was intended as:
“Remedy 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, dreams, and/or want for or receptivity for sexual activity, which causes personal distress or interpersonal difficulties. Low sexual desire might be related to low intercourse, sexual arousal issues or orgasm difficulty”
As noted in my previous policy of female sexual disorder, HSDD is an antiquated term. Nowadays, the DSM-5 talks 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 two to 3 sexually pleasing occasions per month, administration of 300 µg (but neither 150 µg nor 450 µg) was connected to a additional sexually pleasing occasion per month.
For 2 outright reasons, the FDA refused to approve Intrinsa. First, these results are clinically moot. In people already having regular and satisfying sex, a testosterone patch raises the amount of sexually satisfying events by one a month! Second, for this mere one extra satisfying sexual affair, women with surgical menopause who are already taking estrogen would be subjected to another potentially harmful hormone, testosterone. Allow me to clarify.
Throughout the time that P&G applied for approval of its own testosterone patch, everyone was freaking out about results rolling in from the Women’s Health Initiative studies analyzing hormone supplementation. At the time, results from such studies indicated administration of progesterone and estrogen to girls post-hysterectomy increased the risk of cerebrovascular events (think stroke), cardiovascular events and breast cancer.
The FDA concluded that without additional long-term research, it is potentially dangerous to give postmenopausal women testosterone and other hormones. Naturally, P&G’s original study evaluated testosterone supplementation in participants for 52 months at most.
In light of the FDA’s rebuff, P&G watched the futility of pushing the matter and fell Intrinsa. In retrospect, it is evident that P&G estimated that physicians would prescribe the testosterone patch for off-label usage –especially, in girls aside from those who had experienced post-surgery menopause. With lack of long-term study, but the FDA was clearly dismayed by this possibility.
There are additional research findings which also question the potential efficacy of testosterone as an intervention in people with female sexual arousal/interest disorder. To begin with, we do not have evidence of low androgen activity in women with erectile dysfunction. Second, although we can quantify intracrine or intracellular testosterone levels, we can’t measure testosterone levels from the central nervous system. Testosterone levels in the central nervous system likely have the maximum effect on stimulation and desire.
Do Women Need More Testosterone?
To put it differently, we’ve got no idea whether testosterone levels in the brain and spinal cord of people that have female sexual dysfunction is conducive enough to desire exogenous testosterone supplementation, to begin with. Third, in testosterone dyes and stains which were designed to take care of guys, we’ve got no clue how much testosterone actually gets absorbed thus making the custom of testosterone supplementation even more about.
But here is the thing. For a lot of women, access to testosterone in some kind is feasible. For example, girls with female sexual arousal/interest disorder may still be prescribed testosterone gels and patches off-label (taking men’s medication). Testosterone supplements also arrive in several forms which could be purchased over the Internet. At length, 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 fantastic idea to steer clear of the things. Research indicates no real clinical benefit of testosterone supplementation in women with female sexual dysfunction, plus we don’t even know if testosterone levels are more deficient in women with sexual dysfunction in the first place. And, of course, testosterone is a hormone, and hormones are known to have potential adverse consequences for example stroke, blood disorders, cancer and so forth.