Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline

CLINICAL PRACTICE GUIDELINE

Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline

Shalender Bhasin, Glenn R. Cunningham, Frances J. Hayes, Alvin M. Matsumoto, Peter J. Snyder, Ronald S. Swerdloff and Victor M. Montori

Boston University School of Medicine (S.B.), Boston, Massachusetts 02118; Baylor College of Medicine/Veterans Affairs Medical Center (G.R.C.), Houston, Texas 77030; Massachusetts General Hospital/Harvard Medical School (F.J.H.), Boston, Massachusetts 02114; University of Washington/Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; University of Pennsylvania School of Medicine (P.J.S.), Philadelphia, Pennsylvania 19104; Harbor University of California, Los Angeles Medical Center (R.S.S.), Torrance, California 90502; and Mayo Clinic (V.M.M.), Rochester, Minnesota 55905

Objective: The objective was to provide guidelines for the evaluationand treatment of androgen deficiency syndromes in adult men.

Participants: The Task Force was composed of a chair, selectedby the Clinical Guidelines Subcommittee of The Endocrine Society,five additional experts, a methodologist, and a professionalwriter. The Task Force received no corporate funding or remuneration.

Evidence: The Task Force used systematic reviews of availableevidence to inform its key recommendations. The Task Force usedconsistent language and graphical descriptions of both the strengthof recommendation and the quality of evidence, using the recommendationsof the Grading of Recommendations, Assessment, Development,and Evaluation group.

Consensus Process: Consensus was guided by systematic reviewsof evidence and discussions during three group meetings, severalconference calls, and e-mail communications. The drafts preparedby the panelists with the help of a professional writer werereviewed successively by The Endocrine Society’s Clinical Guidelines Subcommittee, Clinical Affairs Committee, and Council.The version approved by the Council was placed on The EndocrineSociety’s web site for comments by members. At each stageof review, the Task Force received written comments and incorporatedneeded changes.

Conclusions:

1. We recommend making a diagnosis of androgen deficiency only in men with consistent symptoms and signs and unequivocally low serum testosterone levels.


2. We suggest the measurement of morning total testosterone level by a reliable assay as the initial diagnostic test.


3. We recommend confirmation of the diagnosis by repeating the measurement of morning total testosterone and in some patients by measurement of free or bio available testosterone level, using accurate assays.


4. We recommend testosterone therapy for symptomatic men with androgen deficiency, who have low testosterone levels, to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density.


5. We recommend against starting testosterone therapy in patients with breast or prostate cancer, a palpable prostate nodule or induration or prostate-specific antigen greater than 3 ng/ml without further urological evaluation, erythrocytosis (hematocrit > 50%), hyperviscosity, untreatedobstructive sleep apnea, severe lower urinary tract symptomswith International Prostate Symptom Score (IPSS) greater than19, or class III or IV heart failure.


6. When testosterone therapyis instituted, we suggest aiming at achieving testosterone levels during treatment in the mid-normal range with any of the approved formulations, chosen on the basis of the patient’s preference, consideration of pharmacokinetics, treatment burden, and cost.


7. Men receiving testosterone therapy should be monitored using a  standardized plan.

Reference:

http://jcem.endojournals.org/cgi/content/full/91/6/1995?linkType=FULL&resid=91/6/1995&journalCode=jcem

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