Updated Clinical Practice Guidelines on Testosterone Therapy in Men With Hypogonadism

Testosterone therapy should be reserved for well-documented cases of hypogonadism, according to updated clinical practice guidelines on testosterone therapy debuted by the Endocrine Society on the opening day of ENDO 2018: The Endocrine Society Annual Meeting, held March 17-20, 2018 in Chicago, Illinois.^1,2

Shalender Bhasin, MD, of Brigham and Women’s Hospital in Boston, Massachusetts and an Endocrine Society-appointed task force provided updates to the 2010 “Testosterone Therapy in Men With Androgen Deficiency Syndromes” guidelines³ as a result of new data from large randomized trials, recent improvements in testosterone measurements, and growing public interest in issues related to men’s health.^1,2 The following is a summary of the recommendations.

Diagnosis of Hypogonadism in Men

• Hypogonadism should be diagnosed in men with symptoms and signs of testosterone deficiency and unequivocally and consistently low serum total testosterone and/or free testosterone concentrations
• Routine screening for hypogonadism is not recommended
• Primary (testicular) and secondary (pituitary–hypothalamic) hypogonadism should be distinguished by measuring serum luteinizing hormone and follicle-stimulating hormone concentrations and the etiology of this dysfunction should be identified

Treatment of Hypogonadism With Testosterone

• Testosterone is recommended in men with hypogonadism to induce and maintain secondary sex characteristics and correct symptoms of deficiency
• Testosterone is not recommended in men planning fertility, men with breast or prostate cancer, a palpable prostate nodule or induration, a prostate-specific antigen (PSA) level >4 ng/mL, a PSA >3 ng/mL combined with a high risk for prostate cancer, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction, or stroke within the last 6 months, or thrombophilia
• For men age 55 to 69 being considered for testosterone therapy with a life expectancy >10 years, potential benefits and risks of evaluating prostate cancer risk and prostate monitoring should be discussed. Prostate cancer risk should be assessed before starting treatment and 3 to 12 months after starting testosterone therapy. In men age 40 to 69 being considered for testosterone therapy who are at increased risk for prostate cancer, prostate cancer risk should be discussed and monitoring options offered
• Routine prescribing of testosterone to all men age ³65 with low testosterone is not recommended. In men age >65 who have symptoms or conditions suggestive of testosterone deficiency and consistently and unequivocally low morning testosterone concentrations, individualized therapy should be offered after discussion of potential risks and benefits
• Short-term testosterone therapy should be considered in HIV-infected men with low testosterone and weight loss to induce and maintain body weight and lean mass gain
• Testosterone therapy for improving glycemic control is not recommended in men with type 2 diabetes who have low testosterone

Monitoring of Testosterone

• Patients should be evaluated after treatment initiation to assess their response to treatment, any adverse effects, and adherence to therapy
• Urological consultation is recommended if, during the first 12 months of treatment, there is a confirmed increase in PSA >1.4 ng/mL above baseline, a confirmed PSA >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                                        

“Relying on the latest and highest quality scientific evidence will help men and their healthcare providers determine when testosterone treatment is appropriate and when it is unlikely to benefit an individual’s health,” Dr Bhasin concluded in a press release.²

References

1. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(5):1-30.
2. Experts issue recommendations to improve testosterone prescribing practices: Endocrine Society releases updated Clinical Practice Guideline on testosterone therapy [press release]. Washington, DC: Endocrine Society. Published March 17, 2018. Accessed March 17, 2018.
3. Bhasin S, Cunningham GR, Hayes FJ, et al; Task Force: Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6):2536-2559.