Cardiovascular Safety of Testosterone Therapy in Older Men with Hypogonadism

Over the years, studies on the cardiovascular (CV) safety of testosterone supplementation have reached varying conclusions. Because of this uncertainty and the growing popularity of testosterone supplementation in older men, the U.S. FDA called on manufacturers in 2015 to address the CV safety of their testosterone products. The first large study to address this concern — the industry-funded TRAVERSE trial — was published in 2023.

This trial involved 5200 older men (mean age, 63) with established CV disease or CV risk factors, two fasting testosterone levels between 100 and 300 ng/dL, and symptoms possibly related to hypogonadism (defined in this study as including decreased libido, erectile dysfunction, fatigue, or low mood). Participants w…