Guidelines Recommend against Testosterone Therapy in Otherwise Healthy Women

Guidelines from the Endocrine Society report that postmenopausal women with hypoactive sexual desire disorder may benefit from up to 6 months of testosterone replacement therapy but recommend against its use in otherwise healthy women.

Guidelines from the Endocrine Society report that postmenopausal women with low sexual desire may benefit from up to 6 months of testosterone replacement therapy but say there’s no other demonstrated benefit to women who receive the treatment.

Even in women with unusually low levels of testosterone, neither direct replacement nor dehydroepiandrosterone (DHEA) is recommended to treat infertility, increase bone health, promote well-being or improve cognitive, cardiovascular or metabolic function.

“We recommend against 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,” wrote the authors of the document.

The guidelines, which appear in the October issue of the Journal of Clinical Endocrinology and Metabolism, reflect nearly a decade of research that has taken place since their last recommendations arrived in 2006.

The Endocrine Society — along with the American Congress of Obstetricians and Gynecologists, American Society for Reproductive Medicine, European Society of Endocrinology, and International Menopause Society — appointed a taskforce to weigh all that new evidence on testosterone and DHEA and suggest modifications to the existing guidelines.

The most important study that members considered was probably a phase III trial of a testosterone patch designed for women, a trial showing that the patch significantly increased sexual desire and sexual function without any severe side effects.

The patch never won approval from the US Food and Drug Administration, which cited concerns about the long-term risk of breast cancer and cardiovascular disease, but the trial has led some American doctors to prescribe low levels of testosterone to female patients who want more sex drive.

The guidelines acknowledge the justification for such treatment but urge caution.

“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,” the authors wrote. “We recommend that any woman receiving T therapy be monitored for signs and symptoms of androgen excess.”

Margaret E. Wierman, MD, the Endocrine Society’s vice president of clinical science and the lead author of the new guidelines, said that most other research indicated that many women with unusually low testosterone levels exhibit no concerning symptoms and that efforts to return levels to normal often produce no measurable effects.

As for DHEA, which is a natural precursor to testosterone, those few studies that have tested it on postmenopausal women have generally found no tangible benefits, but the data are limited. As a result, the new guidelines recommend against the routine use of DHEA on grounds that neither its medical effects nor its safety profile are well understood.

In addition to summarizing existing research and making recommendations, the guideline authors advocate further research in a number of specific areas.

“Ongoing improvement in androgen assays will allow a redefinition of normal ranges across the lifespan,” they write. “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.