Testosterone replacement therapy may not have the benefit many physicians think it does-particularly for women grappling with sexual dysfunction.
Premenopausal women suffering from sexual dysfunction and a low libido don’t have many options for treatment, and a recent study suggests that, while testosterone replacement therapy is often used, there is no evidence to prove its efficacy.
Meanwhile, a survey of urologists and other clinicians found that most physicians recognized an association between libido and testosterone levels in women, but less than half would prescribe testosterone to premenopausal women with low libido.
In a new systematic review on the use of testosterone as a treatment option for premenopausal women with low libido, researchers at the University of Texas Southwestern Medical Center, Dallas say there is little value in testing women’s testosterone levels, and that replacement therapy is unproven and could cause unwanted side effects.
The report, published in the International Journal of Women’s Health (2016; 8:599-607), reviewed 13 research studies and clinical trials conducted between 1995 and 2015. Six out of the 10 testosterone serum evaluation studies showed no significant association between serum testosterone levels and libido, and only one of the four studies examining an intermediate-level testosterone treatment in this population resulted in any improvement in libido.
Forty percent of women in the United States experience self-reported sexual dysfunction, according to the paper, and low libido was the most common complaint. Testosterone is frequently prescribed as an off-label treatment option because there is only one medication-a selective serotonin reuptake inhibitor called flibanserin (Addyi)-approved for this use by the FDA. Testosterone seems like a logical treatment for women, given the long-standing hypotheses about the role of the hormone in female libido, according to the report, but the physiologic role of testosterone in women has not been clearly defined to date.
The review concludes that libido in women is far too complex to treat based on “a simple association with testosterone serum levels.” Low and intermediate doses of the androgen have shown little effect on libido in this population, and using higher levels of testosterone may carry the risk of users developing more male characteristics, including hirsutism, deepening of the voice, clitoral enlargement, and hair loss.
“While avoiding the use of testosterone in premenopausal women limits the pharmacologic options for low libido even further, the limited choice may not justify using a medication that has not been shown to be consistently effective and safe,” the study authors noted.
First author Beverly Reed, MD, says current evidence does not support assessing serum testosterone levels in women with low libido, and that treatment of low libido with testosterone in premenopausal women has not been shown to be effective.
“We emphasize that in the absence of long-term safety data and proven efficacy, physicians should seek other treatment options,” Dr. Reed told Urology Times, adding that treatment of premenopausal women with testosterone has been a rising trend in recent years. “Our hope is that our review educates physicians on the lack of data to support the use of testosterone to treat low libido in premenopausal women. In addition, we hope that our review will prompt researchers to examine new options to help women with low libido.”
Not only is testosterone treatment in premenopausal women unproven in terms of efficacy, but there is also a lack of long-term safety data on this therapy, she adds.
The challenge, she says, is that there are limited treatment options.
“The only FDA-approved option (flibanserin) was recently shown in a meta-analysis to have similar results as a placebo. Given this, more conservative options, such as couples counseling and pelvic floor physical therapy, should be considered. While these options may need further study as well, the safety risks are low and thus, they are reasonable options,” Dr. Reed said.
Another recently published international study examining the use of androgen replacement therapy in both men and women found that 88% of physicians recognized an association between libido and testosterone levels in women, but only 42% would prescribe testosterone to premenopausal women with low libido. More physicians-53%-supported testosterone therapy in postmenopausal women with low libido. Sixty-two percent recommended testosterone replacement in symptomatic men with low testosterone levels.
The study, published in the International Journal of Impotence Research (2016; 28:57-60), polled 133 fellows-mostly urologists-in attendance at the European Society of Sexual Medicine 2014 annual congress. Overall, the poll revealed that there is little consistency among physicians in regard to testosterone replacement therapy for either men or women.
As far as testing was concerned, roughly half of the study participants say they test serum testosterone levels for symptomatic males, and 59% support serum testosterone levels in women with sexual disorders. The report also revealed that while testosterone replacement is effective in men, more research is needed to prove its efficacy in both pre- and postmenopausal women.
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