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Endocrine Society issues revised androgen therapy guidelines for women
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An updated set of clinical practice guidelines for the therapeutic use of androgens in women, revised by an international task force and published in the Journal of Clinical Endocrinology and Metabolism, addresses research on testosterone and dehydroepiandrosterone therapy in women.
Noting an unclear definition for the syndrome, unavailable data to correlate androgen levels with specific symptoms and certain limitations on safety and efficacy, the group outlined areas of focus moving forward including advances in testing and measurement techniques.
“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,” Margaret E. Wierman, MD, of the University of Colorado, Aurora, vice president of clinical science for the Endocrine Society, said in a press release.
Margaret E. Wierman
Changes to the 2006 guidelines were made by a task force appointed by the Endocrine Society, American Congress of Obstetricians and Gynecologists, American Society for Reproductive Medicine, European Society of Endocrinology and International Menopause Society comprising six experts, a methodologist and a medical writer.
Two systematic reviews of published data commissioned by the group, and existing meta-analyses and trials, were considered.
“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, who chaired the task force, said.
The guidelines continue to advise against making a diagnosis of androgen deficiency syndrome in healthy women and add recommendations against:
- The general use of testosterone for: infertility; sexual dysfunction other than hypoactive sexual desire disorder; cognitive, cardiovascular, metabolic or bone health; or general well-being;
- The routine use of dehydroepiandrosterone (DHEA) in normal women or those with adrenal insufficiency;
- And the routine prescription of testosterone or DHEA to treat women with low androgen levels due to hypopituitarism, adrenal insufficiency, surgical menopause, pharmacological glucocorticoid administration or other conditions associated with low levels.
The task force used the Grading of Recommendations Assessment, Development and Evaluation methodology, with recommendation strength indicated by a number 1 (strong, we recommend) or 2 (weak, we suggest).
Through multiple e-mail communications and conference calls, consensus was determined.
Committees from each participating industry organization reviewed the guidelines and commented on the drafts.
The guidelines point to evidence supporting short-term efficacy and safety of high physiological testosterone doses in women with sexual dysfunction due to hypoactive sexual desire disorder during post menopause; but the group underscored that endogenous testosterone levels did not predict treatment response.
With physiological preparations for women unavailable in many countries including the United States, and long-term safety data lacking, the task force recommended monitoring for signs and symptoms of androgen excess.
The guidelines call for improved assays to re-define normal androgen ranges across various ages, which the group contends would help clarify the impact of varying concentrations on biology, physiology and psychology leading to indications for intervention.
“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.”
Disclosures: Please see the clinical practice guidelines for full list of disclosures.
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