Hypogonadism Management and Cardiovascular Health

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In the early days of its use, testosterone therapy faced skepticism regarding its safety and efficacy. After a converging consensus that testosterone therapy was safe and effective for the treatment of hypogonadism, several recent studies showed adverse cardiovascular outcomes associated with testosterone treatment, ultimately resulting in a mandated FDA label warning about the unknown safety of testosterone therapy. Given the clear efficacy of testosterone therapy in the treatment of hypogonadism, establishing the safety of this therapeutic tool is essential. This article summarizes the current evidence regarding the cardiovascular safety of testosterone therapy for the management of hypogonadism, as well as the proposed mechanisms that may explain testosterone’s underlying effects.

*Initiated in 2018, the TRAVERSE trial is a very large, randomized, controlled trial that will likely be sufficiently powered to show clear relationships between TTh and cardiovascular events. The trial randomly assigned 6,000 hypogonadal men at high risk of cardiovascular disease who are ages 45-80 to receive either T gel or placebo. The treatment duration is currently set at 5 years. The primary endpoint for the trial is time to MACE, which includes nonfatal MI, nonfatal stroke, or cardiovascular mortality. The TRAVERSE trial will give a more coherent picture of the outcomes associated with TTh.


Testosterone is clearly a major player in cardiovascular and metabolic health and physiology. Although some epidemiological data show an increase in adverse cardiovascular events with the provision of T, most studies do not support this suggestion. Most RCTs to date are underpowered and do not provide clear, conclusive evidence to repudiate the small numbers of studies that indicate an increased risk. To bolster the evidence regarding the safety of TTh, larger clinical trials such as the TRAVERSE trial will provide key insights. Until then, clinicians should be aware of the overall health impacts of hypogonadism and TTh and advise patients with honest communication about the current evidence.


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