The TRAVERSE study, published in 2023, was the largest randomized trial of testosterone therapy and cardiovascular safety. It found that TRT did not increase the risk of major cardiovascular events in middle-aged and older men with hypogonadism and preexisting or high risk of cardiovascular disease.
For years, the cardiovascular safety of TRT was an open question. Earlier studies produced conflicting results, and the FDA added a warning label in 2015 based on limited evidence. The medical community needed a definitive, large-scale trial — and the TRAVERSE study delivered one.
TRAVERSE enrolled over 5,000 men aged 45 to 80 who had low testosterone and either established cardiovascular disease or multiple risk factors. Half received testosterone gel, half received placebo, and they were followed for an average of nearly three years.
The result: testosterone therapy did not increase the incidence of major adverse cardiovascular events — including heart attack, stroke, or cardiovascular death — compared to placebo. This was a significant finding because it addressed the specific concern that had caused hesitation among providers and patients for a decade.
The study does not mean TRT is risk-free for every individual. Cardiovascular health should always be part of the conversation before starting testosterone, and regular monitoring of hematocrit, blood pressure, and lipids remains important. But TRAVERSE removed the blanket cardiovascular concern that had been holding many men and their doctors back.