(HealthDay News) — Trials should be conducted to better establish the cardiovascular (CV) safety of testosterone therapy, according to a perspective piece published in the New England Journal of Medicine.

Noting that testosterone products have been approved for replacement therapy in men with “classic hypogonadism,” Christine P. Nguyen, MD, from the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland, and colleagues discuss the recent increase in testosterone use among middle-aged and elderly men with “age-related hypogonadism.”

In 2002, the Institute of Medicine concluded that the available evidence was limited and inconclusive on the effects of testosterone therapy in older men. However, older men have been targeted by direct-to-consumer advertising, which implies treatment benefits that are not supported by evidence. 

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Treatment patterns suggest that most men prescribed testosterone have age-related rather than classic hypogonadism. In light of recent large observational studies, these findings are troubling. 

The FDA recently convened an advisory committee that ultimately concluded that evidence supports testosterone therapy only for classic hypogonadism, and that product labels should state that the efficacy and safety has not been established for age-related hypogonadism.

“Given the widespread use of testosterone for age-related hypogonadism, the lack of substantial evidence to support such use, and the unknown effect of the label changes on prescribing patterns, the cardiovascular safety of testosterone products in older men remains an important public health concern,” the researchers wrote.


  1. Nguyen CP et al. N Engl J Med. 2015;373:689-691.