Androgen therapy in women: an Endocrine Society Clinical Practice guideline.

Objective: The objective was to provide guidelines for the therapeutic use of androgens in women.

Participants: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee (CGS) of The Endocrine Society, six additional experts, a methodologist, and a medical writer. The Task Force received no corporate funding or remuneration.

Evidence: The Task Force used systematic reviews of available evidence to inform its key recommendations. The Task Force used consistent language and graphical descriptions of both the strength of recommendation and the quality of evidence, using the recommendations of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) group. The strength of a recommendation is indicated by the number 1 (strong recommendation, associated with the phrase "we recommend") or 2 (weak recommendation, associated with the phrase "we suggest"). The quality of the evidence is indicated by cross-filled circles, such that [1 cross-filled circle, 3 empty circles] denotes very-low-quality evidence, [2 cross-filled circles, 2 empty circles] low quality, [3 cross-filled circles, 1 empty circle] moderate quality, and [4 cross-filled circles] high quality. Each recommendation is followed by a description of the evidence.

Consensus Process: Consensus was guided by systematic reviews of evidence and discussions during one group meeting, several conference calls, and e-mail communications. The drafts prepared by the task force with the help of a medical writer were reviewed successively by The Endocrine Society's CGS, Clinical Affairs Committee (CAC), and Executive Committee. The version approved by the CGS and CAC was placed on The Endocrine Society's web site for comments by members. At each stage of review, the Task Force received written comments and incorporated needed changes.

Conclusions: We recommend against making a diagnosis of androgen deficiency in women at present because of the lack of a well-defined clinical syndrome and normative data on total or free testosterone levels across the lifespan that can be used to define the disorder. Although there is evidence for short-term efficacy of testosterone in selected populations, such as surgically menopausal women, we recommend against the generalized use of testosterone by women because the indications are inadequate and evidence of safety in long-term studies is lacking. A review of the data currently available is presented, and areas of future research are outlined. To formulate clinical guidelines for use of testosterone in women, additional information will be necessary. This includes defining conditions that, when not treated with androgens, have adverse health consequences to women; defining clinical and laboratory parameters that distinguish those with these conditions; and assessing the efficacy and long-term safety of androgen administration on outcomes that are important to women diagnosed with these conditions. This necessary clinical research cannot occur until the biological, physiological, and psychological underpinnings of the role of androgens in women and candidate disorders are further elucidated.