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GUIDELINE TITLE Testosterone Therapy in Men With • When hypogonadism is present, measure luteinizing hormone
Hypogonadism: An Endocrine Society Clinical Practice Guideline (LH) and follicle-stimulating hormone (FSH) to distinguish
between primary hypogonadism (low testosterone, high LH
DEVELOPER Endocrine Society with cosponsorship from the and FSH) and secondary hypogonadism (low testosterone,
European Society of Endocrinology normal or reduced LH and FSH) (strong recommendation,
moderate-quality evidence).
PRIOR VERSION Testosterone Therapy in Men with Androgen • Testosterone therapy is recommended for men diagnosed
Deficiency Syndromes: An Endocrine Society Clinical Practice with hypogonadism to maintain secondary sex characteristics
Guideline, 2010 and to correct symptoms of testosterone deficiency (strong
recommendation, moderate-quality evidence).
• Testosterone therapy is not recommended for men planning
FUNDING SOURCE Endocrine Society
fertility in the near term, with breast or prostate cancer, with
a palpable prostate nodule or induration, a prostate-specific
TARGET POPULATION Adult men with testosterone deficiency antigen (PSA) level >4.0 ng/mL (or >3.0 ng/mL with a high risk of
prostate cancer), elevated hematocrit (>48% or >50% for men
MAJOR RECOMMENDATIONS living at high altitude), untreated obstructive sleep apnea,
severe lower urinary tract symptoms, uncontrolled heart failure,
Testing myocardial infarction or stroke within the last 6 months, or
thrombophilia (strong recommendation, low-quality evidence).
• Hypogonadism can be established in men who have signs and
• For men >65 years who meet the diagnostic criteria for
symptomsoftestosteronedeficiencyandhaveunequivocallylow
hypogonadism, testosterone therapy can be offered after
total testosterone on ⱖ2 measurements. Free testosterone
individualized discussion of the risks and benefits
should be measured when sex hormone–binding globulin
(conditional recommendation, low-quality evidence).
(SHBG) levels may be abnormal, such as in obesity, diabetes,
nephrotic syndrome, hypothyroidism, acromegaly, and in
patients taking steroids or progestins (decreased SHBG Monitoring
levels); or in older age, HIV disease, cirrhosis and hepatitis, • Patients should be evaluated for therapeutic effect, serum
hyperthyroidism, and in patients taking certain anticonvulsants testosterone levels, hematocrit, and PSA levels several times
or those taking estrogen (increased SHBG levels). during the first year of therapy and annually thereafter.
Summary of the Clinical Problem Current clinical practice is often inconsistent with existing
Men with symptoms potentially consistent with hypogonadism standards for management. In one study, 40.2% of 410 019 US
are frequently encountered in clinical practice. The clinical fea- men prescribed testosterone therapy did not have a testosterone
tures associated with true male hypogonadism are nonspecific measurement in the 180 days prior to initiation, and an additional
and include impaired libido, erections, and fertility; reductions 9.8% did not have confirmatory testing. 3 Citing literature in
in lean muscle mass and bone density; loss of facial, axillary, which some studies, but not all, reported therapy-associated car-
and pubic hair; anemia; and changes in mood and vitality. The diovascular risk, in 2015 the US Food and Drug Administration
effects of testosterone on energy, physical performance, mood, issued a warning regarding possible increased risks for myocardial
and cardiometabolic factors continue to be explored, but in infarction and stroke with testosterone therapy, raising further
general, the treatment of hypogonadal younger men often questions about the safety of widespread treatment for aging-
improves symptoms related to testosterone deficiency. In con- related low testosterone levels. This guideline aims to educate cli-
trast, testosterone treatment for middle-aged and older men with nicians and patients on the appropriate diagnosis and treatment
functional decline, even for those with clearly low serum testoste- of true hypogonadism.
rone levels, offers modest and inconsistent benefit.1 Despite such
uncertainties, “low T” clinics and intensive direct-to-consumer Characteristics of the Guideline Source
advertising have contributed to a substantial recent increase in The Endocrine Society is a nonprofit organization established to ad-
testosterone prescribing.2 vance excellence in endocrinology, medical practice, and human
Published Online: March 17, 2018. (11):1159-1166. 7. Roy CN, Snyder PJ, Stephens-Shields AJ, et al.
doi:10.1001/jama.2018.3182 3. Layton JB, Li D, Meier CR, et al. Testosterone lab Association of testosterone levels with anemia in
testing and initiation in the United Kingdom and the older men. JAMA Intern Med. 2017;177(4):480-490.
Conflict of Interest Disclosures: The authors
have completed and submitted the ICMJE Form United States, 2000 to 2011. J Clin Endocrinol Metab. 8. Budoff MJ, Ellenberg SS, Lewis CE, et al.
for Disclosure of Potential Conflicts of Interest. 2014;99(3):835-842. Testosterone treatment and coronary artery plaque
Dr Sargis reports receiving honoraria from 4. Bhasin S, Brito JC, Cunningham GR, et al. volume in older men with low testosterone. JAMA.
CVS Health. No other disclosures were reported. Testosterone Therapy in Men With Hypogonadism: 2017;317(7):708-716.
an Endocrine Society Clinical Practice Guideline. 9. Martinez C, Suissa S, Rietbrock S, et al.
https://academic.oup.com/jcem/article-lookup/doi Testosterone treatment and risk of venous
/10.1210/jc.2018-00229. March 17, 2018. thromboembolism. BMJ. 2016;355:i5968.