October 22, 2014
New Guidelines: Testosterone Therapy Shouldn’t Be Used
in Healthy Women

Washington, D.C.—Androgen deficiency syndrome should not be diagnosed in females, according to a new Endocrine Society guideline that warns against use of testosterone therapy in healthy women.

“Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women,” said lead author Margaret E. Wierman, MD, of the University of Colorado in Aurora, CO, who also serves as the Endocrine Society’s vice president of clinical science.

The new guidelines, published online by the Journal of Clinical Endocrinology and Metabolism, update the society’s 2006 recommendations to address new research concerning testosterone and dehydroepiandrosterone (DHEA) therapy in women, as well as advances in testosterone testing and measurement techniques. Other recommendations in the new guidelines oppose:

• The general use of T [testosterone] for the following indications: infertility; sexual dysfunction other than hypoactive sexual desire disorder; cognitive, cardiovascular, metabolic, or bone health; or general well-being
• The routine use of dehydroepiandrosterone due to limited data concerning its effectiveness and safety in normal women or those with adrenal insufficiency
• The routine prescription of T or dehydroepiandrosterone for the treatment of women with low androgen levels due to hypopituitarism, adrenal insufficiency, surgical menopause, pharmacological glucocorticoid administration, or other conditions associated with low androgen levels because there are limited data supporting improvement in signs and symptoms with therapy and no long-term studies of risk.

“When we reviewed past studies, we found many women who had low testosterone levels measured by older or new techniques did not exhibit any signs or symptoms of concern,” Wierman explained. “As a result, physicians cannot make a diagnosis of androgen deficiency in women.”

This is in contrast to men who, with both symptoms and low levels of testosterone, can be diagnosed with hypogonadism, according to the Society's Clinical Practice Guideline on Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes.

A diagnosis of hypoactive sexual desire disorder (HSDD) is the only situation where the Endocrine Society suggests prescribing testosterone therapy for women—and then only after a 3- to 6-month trial to see if testosterone therapy improves sexual function. HSDD occurs when women have no interest in sex and that lack of interest causes personal distress.

On the other hand, the clinical practice guideline recommends that physicians avoid prescribing testosterone on an off-label basis to improve sexual dysfunction in women who do not have HSDD. The new guideline points out that use of testosterone in women has been linked to changes in cholesterol as well as conditions such as acne and hirsutism. In addition, long-term risks to the breast or cardiovascular system are unknown.

“Currently, there isn’t enough evidence that any benefits outweigh the risks to most women,” Wierman said. “More research is needed to determine the long-term safety of testosterone therapy in postmenopausal women.”

“At present, physiological T preparations for use in women are not available in many countries including the United States, and long-term safety data are lacking. We recommend that any woman receiving T therapy be monitored for signs and symptoms of androgen excess,” the guideline states.

Review of the use of DHEA therapy, meanwhile, indicated no significant benefit when given to normal women or those with adrenal insufficiency.

In the guideline, the Endocrine Society calls for better testing and measurement. “Ongoing improvement in androgen assays will allow a redefinition of normal ranges across the 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 authors suggest.

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