Testosterone & the Heart
What the 2025 label update means for you.
In February 2025 the FDA removed cardiovascular-risk language from the Boxed Warning across all testosterone products, following the TRAVERSE trial.
TRAVERSE enrolled 5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk. Testosterone was noninferior to placebo for major adverse cardiac events.
Noninferior means not worse than placebo. The trial measured safety rather than heart benefit, which is why your plan still tracks your cardiovascular markers.
A warning about increased blood pressure was added across all testosterone products, so blood pressure is monitored throughout your program.
The FDA retained its Limitation of Use language for age-related hypogonadism, which is why every prescription follows a full clinical evaluation.
Source: FDA class-wide labeling changes for testosterone products, February 2025.



