Nancy A. Melville
September 02, 2019
The first broad consensus on the role of testosterone treatment for women is available in a new global position statement from multiple international medical societies.
Existing evidence clearly shows that testosterone is beneficial in the treatment of sexual desire dysfunction in postmenopausal women, but not for any other conditions or symptoms, the authors conclude.
Susan Ruth Davis, PhD, president of the International Menopause Society, which led the international task force that issued the statement, said the consensus should put clinicians at ease in prescribing testosterone for postmenopausal hypoactive sexual desire dysfunction (HSDD) but not other conditions.
Clinicians commonly prescribe testosterone to women off label for HSDD, as well as for a variety of other symptoms, including low mood, depression, fatigue, memory loss, hot flushes, migraine, and breast cancer prevention. The evidence regarding efficacy for these symptoms is either weak or nonexistent, Davis explained.
"It is well established that testosterone levels do not change with natural menopause," she told Medscape Medical News.
"It is not an effective treatment for menopausal symptoms, including hot flushes, night sweats, anxiety, low mood, sleep disruptions," said Davis, who is also a professor of women's health and director of the Women's Health Research Program at Monash University, in Melbourne, Australia.
The consensus ? published simultaneously this week in four journals: the Journal of Clinical Endocrinology and Metabolism, Climacteric, Maturitas, and the Journal of Sexual Medicine ? is based on an expansive review of evidence, including a recent systematic review and meta-analysis of testosterone in women, as reported by Medscape Medical News in July, as well as the opinions of multidisciplinary experts, including many in the leading medical organizations that contributed to the statement.
In addition to the International Menopause Society, the organizations include the Endocrine Society, the American College of Obstetricians and Gynecologists, the North American Menopause Society, the European Menopause and Andropause Society, the International Society for the Study of Women's Sexual Health, the Royal College of Obstetricians and Gynaecologists, the International Society for Sexual Medicine, the Federacion Latinoamericana de Sociedades de Climaterio y Menopausia, the International Society of Endocrinology, the Endocrine Society of Australia, and the Royal Australian and New Zealand College of Obstetricians and Gynecologists.
HSDD Evidence Only Applies to Postmenopausal Women
HSDD is the only condition for which testosterone treatment has been proven to be beneficial to women. For women with HSDD, the available evidence shows improved sexual desire, arousal, orgasm, and pleasure, together with reduced concerns and distress about sex.
HSDD is estimated to occur in approximately 32% of women in midlife. However, the consensus statement underscores that the evidence only shows that testosterone treatment is beneficial for women who are postmenopausal.
"Larger studies are needed to inform clinical recommendations regarding the use of testosterone for HSDD in premenopausal women," the statement concludes.
Furthermore, the statement recommends that blood total testosterone levels not be used to diagnose HSDD.
Adjust Male Formulations of Testosterone Accordingly for Female Dose
Existing testosterone preparations are only designed for men. Because there are no approved testosterone formulations for women anywhere in the world, clinicians typically use either formulations approved for men with doses adjusted for women, or compounded therapies.
The consensus statement recommends that "male formulations can be used judiciously in small doses, with blood testosterone concentrations monitored regularly."
Importantly, treatment should target blood concentrations of testosterone that approximate what is normal for premenopausal women, and no higher, the statement recommends.
Compounded testosterone is not recommended unless a regulatory-approved product is not otherwise available.
Potential Risks Addressed
The report addresses potential cardiovascular risks of testosterone. It indicates that oral testosterone therapy is associated with negative effects on lipid and cholesterol levels and therefore is not recommended. Non-oral therapies "in doses that approximate physiological testosterone concentrations for premenopausal women have shown no statistically significant adverse effects on lipid profiles over the short term," it states.
In terms of breast health, evidence shows that testosterone therapy does not increase mammographic breast density, and "available data suggest that short-term transdermal testosterone therapy does not impact breast cancer risk."
However, randomized controlled trials typically exclude women with cardiovascular risk factors; therefore, the conclusions cannot be generalized to those at risk.
Furthermore, the safety of long-term testosterone therapy in women has not been established.
Testosterone Use in Women Common; Evidence Commonly Weak
Although Davis stressed that any use of testosterone should be avoided for any symptoms in which the evidence is unfounded, the greatest concern is in its use for "conditions where failure to receive appropriate treatment might result in harm to the woman, such as depression or fatigue with a serious underlying cause," she noted.
There is also a problem regarding "the use of high testosterone doses that may cause masculinization and long-term harm to the woman," she said.
She noted that the consensus statement should ultimately help provide conclusive guidance for a treatment that has been widely prescribed despite significant uncertainty.
"Up until now, there has been no independent, thorough review of all available evidence, so findings from small studies have been overinterpreted, whether they be positive or negative," she observed.
"This position statement has far-reaching global consequences.
"It not only reassures clinicians that a trial of testosterone therapy is appropriate for women with HSDD but very emphatically states that, at present, the available evidence does not support the use of testosterone for any other symptoms or medical condition," she reiterated.
Davis has received speaker honoraria from Pfizer Australia and Besins Healthcare and has provided expert advice to Besins Healthcare about menopause. She is also a consultant to Que Oncology.