Full Guideline: Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice GuidelineJCEM | March 2018

Shalender Bhasin, Juan P. Brito, Glenn R. Cunningham, Frances J. Hayes, Howard N. Hodis, Alvin M. Matsumoto, Peter J. Snyder, Ronald S. Swerdloff, Frederick C. Wu, Maria A. Yialamas

Differences between the 2010 and 2018 guidelines:

+1.0 Diagnosis of Hypogonadism in Men

1.1 We recommend diagnosing hypogonadism in men with symptoms and signs of testosterone deficiency and unequivocally and consistently low serum total testosterone and/or free testosteroneconcentrations (when indicated). (1 |O)

1.2 We recommend against routine screening of men in the general population for hypogonadism. (1 |OO)

1.3 In men who have hypogonadism, we recommend distinguishing between primary (testicular) and secondary (pituitaryhypothalamic) hypogonadism by measuring serum luteinizing hormone and follicle stimulating hormone concentrations. (1 |O)

1.4 In men with hypogonadism, we suggest further evaluation to identify the etiology of hypothalamic, pituitary, and/or testicular dysfunction. (2 |OO)

+2.0 Treatment of Hypogonadism with Testosterone

2.1 We recommend testosterone therapy in hypogonadal men to induce and maintain secondarysex characteristics and correct symptoms of testosterone deficiency. (1 |O)

2.2. We recommend against testosterone therapy in men planning fertility in the near term or in men with breast or prostate cancer, a palpable prostate nodule or induration, a prostate-specific antigen level >4 ng/mL, a prostate-specific antigen level >3 ng/mL combined with a high risk of prostate cancer(without further urological evaluation), elevated hematocrit, untreated severe obstructive sleep apnea,severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke withinthe last 6 months, or thrombophilia. (1 |OO)

2.3 In hypogonadal men 55 to 69 years old, who are being considered for testosterone therapy andhave a life expectancy >10 years, we suggest discussing the potential benefits and risks of evaluatingprostate cancer risk and prostate monitoring and engaging the patient in shared decision makingregarding prostate cancer monitoring. For patients who choose monitoring, clinicians should assessprostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone. (2 |OOO) In hypogonadal men being considered for testosterone therapy who are 40 to69 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degreerelative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient andoffering monitoring options. (2 |OOO)

2.4 We suggest against routinely prescribing testosterone therapy to all men 65 years or older withlow testosterone concentrations (1 |OO). In men.65 years who have symptoms or conditionssuggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistentlyand unequivocally low morning testosterone concentrations, we suggest that clinicians offertestosterone therapy on an individualized basis after explicit discussion of the potential risks andbenefits. (2 |OO)

2.5 We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded)to induce and maintain body weight and lean mass gain. (2 |OO)

2.6 In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommendagainst testosterone therapy as a means of improving glycemic control. (1 |OO)

+3.0 Monitoring of Testosterone Replacement Therapy

3.1 In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen. (Ungraded Good Practice Statement)

3.2 We recommend a urological consultation for hypogonadal men receiving testosterone treatmentif during the first 12 months of testosterone treatment there is a confirmed increase in prostate specificantigen concentration >1.4 ng/mL above baseline, a confirmed prostate-specific antigen >4.0 ng/mL, or a prostatic abnormality detected on digital rectal examination. After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient. (2 |OO)

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Testosterone Therapy for Hypogonadism Guideline Resources ...

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