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Global position statement calls for testosterone formulations for women
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A coalition of 11 leading medical societies worldwide released a global position statement outlining best practices for the use of testosterone for women, stating the therapy is appropriate for women with hypoactive sexual desire disorder/dysfunction but noting that evidence does not support such treatment for any other symptoms or medical conditions.
The position statement, published simultaneously in four international medical journals, provides expert agreement for the first time about how testosterone should be measured in women and therapy prescribed. It calls on industry, researchers and funding organizations to recognize the need for further research into testosterone therapy for women of all ages and the development and licensing of products formulated specifically for women.
“There are no clearly established indications for testosterone therapy for women,” Susan Davis, MBBS, FRACP, PhD, FAHMS, professor in the School of Public Health and Preventive Medicine at Monash University in Australia, and colleagues wrote in the statement. “Nonetheless, clinicians have treated women with testosterone for decades, with the intention of alleviating a variety of symptoms, with uncertain benefits and risks. In most countries, testosterone therapy is prescribed off-label, such that women are using either testosterone formulations approved for men with dose modification or compounded therapies. Because of these issues, there is a compelling case for a global consensus position statement on testosterone therapy for women based on the available evidence from placebo/comparator randomized controlled trials.”
Preparations for women needed
The authors wrote that testosterone can be effective at improving sexual well-being for postmenopausal women with hypoactive sexual desire disorder/dysfunction (HSDD). Recognized benefits are improved sexual desire, arousal, orgasm and pleasure, together with reduced concerns and distress about sex.
“We do not have evidence to support the use of testosterone for other issues, such as cognitive function, well-being in mood, bone mineral density or musculoskeletal health, but it does not seem to have a negative effect,” Sharon Parish, MD, professor of clinical medicine and professor of medicine in clinical psychiatry at Weill Cornell Medical College, told Endocrine Today. “The specific finding of benefit for sexual function is still maintained. The bottom line is, the only evidence-based indication is for postmenopausal women with HSDD. We need preparations that are specifically approved, worldwide, for women.”
The statement also advises that when testosterone therapy is given, the resultant blood levels should not be above those observed in healthy young women, Davis said in a press release.
“We hope this will allow women who may benefit to be offered treatment, and simultaneously protect women from receiving inappropriate testosterone therapy,” Davis said in the release.
Parish said the key messages for clinicians and researchers who care for and study postmenopausal women are that testosterone has positive benefits on sexual function, minimal adverse effects and low risk profiles.
“A lot of the questions that we asked in putting together this statement have been asked before,” Parish said in an interview. “With this statement, key issues are now more definitive than in the past, such as how you should measure androgens and what androgens should be measured. In terms of cardiovascular risk, testosterone does not seem to confer CV risk, but it also does not confer CV benefit.”
As Endocrine Today previously reported, a meta-analysis of 36 randomized controlled trials published in July in The Lancet Diabetes & Endocrinology noted that postmenopausal women assigned to testosterone therapy reported improvements in a variety of sexual domains vs. women assigned to placebo or estrogen, such as frequency in satisfying events, arousal and orgasm. The analysis of 8,480 premenopausal or postmenopausal women assessed testosterone treatment of at least 12 weeks’ duration, including 13 studies that specifically recruited women with low sexual function. Researchers found that, compared with placebo or a comparator (estrogen, with or without progestogen), testosterone increased the frequency of satisfying sexual events (mean difference, 0.85; 95% CI, 0.52-1.18), sexual desire (standardized mean difference, 0.36; 95% CI, 0.22-0.5), pleasure (mean difference, 6.86; 95% CI, 5.19-8.52), arousal (standardized mean difference, 0.28; 95% CI, 0.21-0.35) and orgasm (standardized mean difference, 0.25; 95% CI, 0.18-0.32) among postmenopausal women.
More research needed
Parish said future trials with testosterone therapy in women should provide more data on other outcomes and safety issues and use “more contemporary endpoints” that assess true global sexual function.
The statement was developed by a multinational, multidisciplinary task force and is endorsed by the International Menopause Society, the Endocrine Society, the European Menopause and Andropause Society, the International Society for Sexual Medicine, the International Society for the Study of Women's Sexual Health, the North American Menopause Society, the Federacion Latinoamericana de Sociedades de Climaterio y Menopausia, the Royal College of Obstetricians and Gynaecologists, the International Society of Endocrinology, the Endocrine Society of Australia, and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
“With this statement, leading societies with differing viewpoints are coming together with one common message disseminated to leaders in the field,” Parish said. “This provides a less murky message for clinicians and researchers worldwide that will, hopefully, help move some of these challenges forward. We hope a pharmaceutical company will be motivated to create a female product.” – by Regina Schaffer
Disclosures: Davis reports she has received honoraria from Besins and Pfizer Australia and served as a consultant for Besins Healthcare, Mayne Pharmaceuticals, Lawley Pharmaceuticals and Que Oncology, and is an investigator for Que Oncology. Parish reports she has served as a consultant for AMAG Pharmaceuticals, Dare Bioscience, JDS Therapeutics, Procter & Gamble, Sprout, Strategic Science & Technologies and Therapeutics MD, served on an advisory board for AMAG Pharmaceuticals and has received writing support from AMAG, Sprout and Therapeutics MD. Please see the study for all other authors’ relevant financial disclosures.
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