Testosterone Therapy: Review of Clinical Applications

 

Testosterone therapy is increasingly common in the United States, and many of these prescriptions are written by primary care physicians. There is conflicting evidence on the benefit of male testosterone therapy for age-related declines in testosterone. Physicians should not measure testosterone levels unless a patient has signs and symptoms of hypogonadism, such as loss of body hair, sexual dysfunction, hot flashes, or gynecomastia. Depressed mood, fatigue, decreased strength, and a decreased sense of vitality are less specific to male hypogonadism. Testosterone therapy should be initiated only after two morning total serum testosterone measurements show decreased levels, and all patients should be counseled on the potential risks and benefits before starting therapy. Potential benefits of therapy include increased libido, improved sexual function, improved mood and well-being, and increased muscle mass and bone density; however, there is little or mixed evidence confirming clinically significant benefits. The U.S. Food and Drug Administration warns that testosterone therapy may increase the risk of cardiovascular complications. Other possible risks include rising prostate-specific antigen levels, worsening lower urinary tract symptoms, polycythemia, and increased risk of venous thromboembolism. Patients receiving testosterone therapy should be monitored to ensure testosterone levels rise appropriately, clinical improvement occurs, and no complications develop. Testosterone therapy may also be used to treat hypoactive sexual desire disorder in postmenopausal women and to produce physical male sex characteristics in female-to-male transgender patients.

The use of testosterone therapy is increasingly common in the United States, with an estimated 2.3 million American men receiving the therapy in 2013.1 More than one-half of testosterone prescriptions are written by primary care physicians.2 Most of these prescriptions are for middle-aged and older men with age-related declines in testosterone,1 despite inconclusive data on testosterone therapy's safety and effectiveness for this indication.

WHAT IS NEW ON THIS TOPIC: TESTOSTERONE THERAPY

Male hypogonadism should be diagnosed only if there are signs or symptoms of hypogonadism and total serum testosterone levels are low on at least two occasions.

The U.S. Food and Drug Administration clarified in 2015 that prescribing testosterone for low testosterone levels due to aging constitutes off-label use.

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SORT: KEY RECOMMENDATIONS FOR PRACTICE

Clinical recommendationEvidence ratingReferences

Testosterone therapy should be considered for men with low testosterone levels and clinical symptoms of hypogonadism, particularly sexual dysfunction.

B

10, 1223, 2537

Before starting treatment, male hypogonadism should be documented with low morning testosterone levels on two occasions.

C

9

Men considering testosterone therapy should be counseled about the uncertainty of the long-term safety of testosterone, including possible cardiovascular harms, and patients and physicians should engage in shared decision making, weighing the risks and benefits of therapy.

C

9, 11, 38

Men receiving testosterone therapy should be monitored regularly for adverse effects and treatment effectiveness, including testosterone measurements, complete blood count to measure hematocrit, and prostate-specific antigen testing.

C

9, 11

Testosterone therapy may be considered for treatment of postmenopausal women with hypoactive sexual desire disorder.

B

65


A = consistent, good-quality patient-oriented evidence; B = inconsistent or limited-quality patient-oriented evidence; C = consensus, disease-oriented evidence, usual practice, expert opinion, or case series. For information about the SORT evidence rating system, go to http://www.aafp.org/afpsort.

SORT: KEY RECOMMENDATIONS FOR PRACTICE

Clinical recommendationEvidence ratingReferences

Testosterone therapy should be considered for men with low testosterone levels and clinical symptoms of hypogonadism, particularly sexual dysfunction.

B

10, 1223, 2537

Before starting treatment, male hypogonadism should be documented with low morning testosterone levels on two occasions.

C

9

Men considering testosterone therapy should be counseled about the uncertainty of the long-term safety of testosterone, including possible cardiovascular harms, and patients and physicians should engage in shared decision making, weighing the risks and benefits of therapy.

C

9, 11, 38

Men receiving testosterone therapy should be monitored regularly for adverse effects and treatment effectiveness, including testosterone measurements, complete blood count to measure hematocrit, and prostate-specific antigen testing.

C

9, 11

Testosterone therapy may be considered for treatment of postmenopausal women with hypoactive sexual desire disorder.

B

65


A = consistent, good-quality patient-oriented evidence; B = inconsistent

The Authors

show all author info

RYAN C. PETERING, MD, is an assistant professor in the Department of Family Medicine at the Oregon Health and Science University, Portland....

NATHAN A. BROOKS, MD, MPH, is a third-year resident in the Department of Family Medicine at the Oregon Health and Science University.

Author disclosure: No relevant financial affiliations.

Address correspondence to Ryan C. Petering, MD, Oregon Health and Science University, 4411 SW Vermont St., Portland, OR 97219 (e-mail: petering@ohsu.edu). Reprints are not available from the authors.

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