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New Guidelines for Testosterone Therapy in Women: Recent Research Context

– New position statement recommends testosterone therapy for just one condition


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Expert Critique

FROM THE ASCO Reading Room
Sean J. Iwamoto, MD
Sean J. Iwamoto, MD Assistant Professor University of Colorado School of Medicine, Division of Endocrinology, Metabolism & Diabetes; Rocky Mountain Regional VA Medical Center Co-Founder
Full Critique

A new position statement, created by a task force representing several leading organizations, outlines new recommendations for testosterone therapy in women.

According to first author Susan Davis, a researcher with the School of Public Health and Preventive Medicine at Monash University in Australia, and colleagues, writing in , the statement was created because "there are no clearly established indications for testosterone therapy for women," and that in turn is creating a vacuum in how and when testosterone treatments are used in women.

"Clinicians have treated women with testosterone for decades, with the intention of alleviating a variety of symptoms, with uncertain benefits and risks," Davis and colleagues wrote. "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."

Using evidence from randomized controlled trials of at least 12 weeks' duration, the task force intended to offer "clear guidance as to which women might benefit from testosterone therapy, to identify symptoms, signs, and conditions for which evidence does not support the prescribing of testosterone, to explore areas of uncertainty, and to identify any prescribing practices that have the potential to cause harm."

Following their analysis, task force members concluded that current evidence was sufficient to recommend testosterone therapy in women with only one condition: hypoactive sexual desire disorder/dysfunction (HSDD). As such, Davis and colleagues called for more research into testosterone therapy in women.

"There are insufficient data to support the use of testosterone for the treatment of any other symptom or clinical condition [other than HSDD], or for disease prevention," Davis and colleagues wrote.

In the meantime, the task force made recommendations on a variety of topics, including:

• Measuring circulating testosterone in women

• Terminology for female sexual dysfunction

• Associations between endogenous androgen concentrations and female sexual function

• Testosterone treatment for naturally or surgically postmenopausal women with HSDD, with or without concurrent estrogen therapy

• Effects of testosterone on well-being, mood, and cognition in postmenopausal women

• Musculoskeletal effects of testosterone

• Possible side effects of testosterone therapy

• Testosterone therapy and cardiovascular health

• Testosterone therapy and breast health

• Potential serious adverse events of testosterone therapy in women

• Assessing female sexual dysfunction before commencing testosterone therapy

• Testosterone therapy and postmenopausal women

• Other androgenic preparations

• Design of future trials of physiologically-dosed testosterone

Davis reported receiving honoraria from Besins and Pfizer Australia; has been a consultant to Besins Healthcare, Mayne Pharmaceuticals, Lawley Pharmaceuticals and Que Oncology; and is an investigator for Que Oncology (money paid to her institution).

Primary Source

The Journal of Clinical Endocrinology and Metabolism

Source Reference:

Endocrine Society Publications Corner

Endocrine Society Publications Corner