Guideline issued on androgen therapy in women

The Endocrine Society released an updated clinical practice guideline on androgen therapy in women.

The Endocrine Society released an updated clinical practice guideline on androgen therapy in women.

A task force used 2 systematic reviews of published data as well as existing meta-analyses and trials to update the Endocrine Society's 2006 guideline on this topic. The task force included representatives from the Endocrine Society, the American Congress of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the European Society of Endocrinology, and the International Menopause Society, along with a methodologist and a medical writer. The task force's recommendations were graded as 1 (strong recommendation, we recommend) or 2 (week recommendation, we suggest).

The guideline appears in the October Journal of Clinical Endocrinology and Metabolism.

The task force recommended against diagnosing androgen deficiency syndrome in healthy women because such a syndrome is not well defined and there are no data to correlated androgen levels with specific signs or symptoms. It also recommended against general use of testosterone for infertility; sexual dysfunction besides hypoactive sexual desire disorder; cognitive, cardiovascular, metabolic, or bone health; or general well-being, as well as routine use of dehydroepiandrosterone (DHEA), since data on effectiveness and safety in normal women and women with adrenal insufficiency are limited.

In addition, the task force recommended against routinely prescribing testosterone or DHEA for women with low androgen levels as a result of hypopituitarism, adrenal insufficiency, surgical menopause, pharmacological glucocorticoid administration, or other conditions associated with low androgen levels, since limited data are available to support improved signs and symptoms with therapy and no long-term studies of risk have been done.

The task force did note that evidence supports short-term efficacy and safety of high physiological doses of testosterone treatment in postmenopausal women with sexual dysfunction because of hypoactive sexual desire disorder (HSDD). It suggested a 3- to 6-month trial of testosterone “for postmenopausal women who request therapy for properly diagnosed HSDD and in whom therapy is not contraindicated resulting in a midnormal premenopausal value in a reference assay to avoid pharmacological [testosterone] administration.” However, it said that endogenous testosterone levels didn't predict response to therapy and long-term data on physiological testosterone preparations for women (none of which are available in the United States) are lacking. The task force suggested that women receiving testosterone therapy be monitored for androgen excess and that therapy be stopped if women have not responded by 6 months.

Areas of future research include trials of androgen therapy that assess safety and risk with multiple end points, such as sexual function, mood, and cognitive and endometrial health. The task force also improvement in androgen assays to allow redefinition of normal ranges across a woman's lifespan. “This may help to clarify the impact of varying concentrations of plasma androgens on the biology, physiology, and psychology in women and lead to indications for therapeutic interventions,” the task force concluded.