At a glance
- The TRAVERSE trial did not show a meaningful increase in major cardiovascular events versus placebo in its studied population
- FDA removed boxed-warning language about increased cardiovascular outcomes in 2025
- FDA added class-wide warnings about increased blood pressure
- Results from one trial do not make therapy appropriate for every patient
What changed in the evidence?
The FDA-required TRAVERSE trial followed more than 5,200 men with hypogonadism and cardiovascular disease or risk factors. In that population, major adverse cardiovascular events occurred at similar rates in the testosterone and placebo groups.
After reviewing the trial and other evidence, FDA removed language from the boxed warning about increased adverse cardiovascular outcomes. This does not mean testosterone prevents heart disease or is risk-free.
What still requires attention?
- Testosterone products can increase blood pressure.
- Hematocrit can rise and should be monitored.
- The diagnosis and medical indication need to be accurate.
- Recent cardiovascular events, uncontrolled conditions, sleep apnea, thrombophilia, fertility goals, and prostate risk can change the decision.
- Long-term safety questions remain, especially outside the populations studied in major trials.