Global consensus statement on using testosterone therapy for women

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For the first time, a global consensus position statement on use of testosterone therapy for women with low sexual desire has been published in various medical journals. The statement-which is completed and should be read in its entirety-was prompted because of the uncertain benefits and risks of treating women with testosterone. In many countries, the therapy is prescribed off-label, using either testosterone formulations approved for men with dose modification, or as compounded therapies.

“There is a need to delineate, based on available evidence, when a trial of testosterone therapy is appropriate, to enable women who might benefit to be treated, and equally when it is inappropriate to protect women against inappropriate treatment,” said lead author Susan Davis MBBS, FRACP, PhD, FAHMS, president of the International Menopause Society and chair of Women's Health at Monash University in Melbourne, Australia. 

Dr. Davis told Contemporary OB/GYN that testosterone therapy is effective in women with low sexual desire that causes them distress, as long as their blood levels are within the normal premenopausal range.

There is currently no other clinical indication for testosterone therapy for women, according to Dr. Davis. 

“In such women, there is no evidence of serious adverse events,” she said. “Few women will experience an increase in hair growth or acne, and when either occurs the effects are mild.”

Therapy does not cause alopecia, clitoromegaly or voice change. However, the safety of long-term testosterone therapy has not been determined.

The recommendations are based on findings from blinded placebo/comparator randomized clinical trials (RCTs) of at least 12 weeks’ duration of reported outcomes. The authors noted that the diagnosis of hypoactive sexual desire disorder/dysfunction (HSDD) should include a full clinical assessment. Other factors contributing to female sexual dysfunction (FSD) must also be identified and addressed before beginning testosterone therapy. But a blood total testosterone level should not be used to diagnose HSDD.

Treatment of HSDD should be limited to testosterone formulations that achieve blood concentrations of testosterone that approximate premenopausal physiological concentrations. Given the absence of any approved female product by a national regulatory body, male formulations can be judiciously used in female doses, but blood testosterone concentrations must be routinely monitored.

The statement recommends against using compounded testosterone. In  addition, data are insufficient on which to base a recommendation for use of testosterone in premenopausal women to treat sexual function or any other outcome.

Conversely, testosterone therapy does not increase mammographic breast density nor does short-term transdermal testosterone therapy impact breast cancer risk. However, data from the RCTs are insufficient to gauge long-term breast cancer risk.

But there is strong evidence in the literature that appropriate testosterone treatment benefits sexual function, with an average of one satisfying sexual event per month and increases in the subdomains of sexual desire, arousal, orgasmic function, pleasure and sexual responsiveness, along with a reduction in sexual distress.

“It is our hope that our global consensus statement will encourage regulators to approve a testosterone formulation for women,” Dr. Davis said.

The statement also advocates more research on testosterone therapy for women, plus developing and licensing testosterone products indicated specifically for women.The position statement has been endorsed by more than a dozen leading societies, including the International Menopause Society, The Endocrine Society, The European Menopause and Andropause Society, and The International Society for Sexual Medicine.

Disclosures:

Susan Davis receives honoraria from Besins Healthcare and Pfizer Australia. She is also a consultant to Que Oncology.