Testosterone therapy should be prescribed to men with age-related low testosterone levels only to treat sexual dysfunction, according to a new evidence-based clinical practice guideline from the American College of Physicians (ACP), published in the Annals of Internal Medicine.

In the systematic review, ACP’s Clinical Guidelines committee examined 38 randomized controlled trials lasting at least 6 months as well as 20 long-term observational studies. They evaluated clinical outcomes using the GRADE system for sexual function, physical function, quality of life, energy/vitality, depression, cognition, serious adverse events, and major adverse cardiovascular events. Analyses showed that global sexual function improved by 35% and erectile function by 27% with testosterone therapy compared with no treatment.

“The evidence shows that men with age-related low testosterone may experience slight improvements in sexual and erectile function,” ACP president Robert M. McLean, MD, stated in a news release. “The evidence does not support prescribing testosterone for men with concerns about energy, vitality, physical function, or cognition.”

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According to the guideline, clinicians can discuss testosterone treatment with hypogonadal men who have sexual dysfunction. Clinicians should reevaluate symptoms within 12 months (and periodically thereafter) and discontinue treatment if there is no improvement. The guideline does not address testosterone monitoring or hypogonadism diagnosis.

“These guidelines agree fairly closely with guidelines recently proposed by the Endocrine Society and the American Urological Association,” E. Victor Adlin, MD, of Lewis Katz School of Medicine at Temple University in Philadelphia, commented in an accompanying editorial. “Those organizations agree that treatment should be offered to older men with diminished sexual function and well-documented low testosterone levels but should not be used for the less specific symptoms of fatigue and loss of vitality.”

The ACP recommends intramuscular testosterone injections over transdermal formulations due to their similar safety profiles but substantial cost difference: $156 vs $2135 in 2016. “Most men are able to inject the intramuscular formulation at home and do not require a separate clinic or office visit for administration,” Dr McLean stated.

With respect to serious adverse events from treatment, no trials were adequately powered to assess cardiovascular events, thromboembolic disease, prostate cancer, or death.

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Qaseem A, Horwitch CA, Vijan S, et al. Testosterone treatment in adult men with age-related low testosterone: A clinical guideline from the American College of Physicians. Ann Intern Med. doi:10.7326/M19-0882

ACP issues guideline for testosterone treatment in adult men with age-related low testosterone. American College of Physicians; January 7, 2020.

Adlin EV. Age-related low testosterone. Ann Intern Med. doi:10.7326/M19-3815

Diem SJ, Greer NL, MacDonald R, et al. Efficacy and safety of testosterone treatment in men: An evidence report for a clinical practice guideline by the American College of Physicians. Ann Intern Med. doi:10.7326/M19-0830