Testosterone Therapy and Heart Health: What the TRAVERSE Trial Found

The TRAVERSE trial, a large randomized study of more than 5,000 men with low testosterone and cardiovascular risk factors, found that testosterone therapy was not associated with an increased rate of major heart events compared with placebo. Published in the New England Journal of Medicine in 2023 and followed by FDA label changes in February 2025, it is the strongest cardiovascular safety evidence to date on testosterone therapy. At Zest Regen Health in Columbia, Maryland, testosterone care still starts the same way: documented symptoms, repeated morning blood work, and a physician review of risks, benefits, and monitoring.

What did the TRAVERSE trial study?

TRAVERSE randomized 5,246 men between the ages of 45 and 80 who had confirmed low testosterone and preexisting cardiovascular disease or high cardiovascular risk to a daily transdermal testosterone gel or a matching placebo gel. Participants were followed for a median of about 33 months, and the trial was designed around major adverse cardiovascular events: heart attack, stroke, or cardiovascular death.

What did the trial find?

Over the study period, 7.0% of men in the testosterone group and 7.3% of men in the placebo group experienced a major cardiovascular event, a difference small enough that the trial concluded testosterone therapy was not associated with an increased cardiovascular risk. The trial also recorded higher rates of some individual events in the testosterone group, including atrial fibrillation, acute kidney injury, and pulmonary embolism, along with a small rise in systolic blood pressure. Those findings are why monitoring remains a required part of therapy.

What did the FDA change in 2025?

In February 2025, the FDA announced class-wide label changes for testosterone products based on the TRAVERSE results. The agency added the trial results to product labels and removed the boxed warning about cardiovascular events and venous thromboembolism, while retaining language noting that the safety and effectiveness of testosterone therapy for age-related low testosterone without a diagnosed condition have not been established.

What this means for men considering therapy

The TRAVERSE results are reassuring, but they are not a reason to skip the evaluation. Guidelines continue to require symptoms of testosterone deficiency together with consistently low fasting morning testosterone confirmed on repeat testing before therapy is considered.

• A diagnosis of hypogonadism requires symptoms plus low testosterone on repeated morning labs
• Blood pressure and hematocrit are rechecked on a schedule during therapy
• Label language notes that effectiveness for age-related decline without a diagnosed condition is not established
• Certain conditions, including some prostate and breast cancers and uncontrolled heart failure, rule out therapy

Testosterone care in Columbia, Maryland

Zest Regen Health is located at 8860 Columbia 100 Parkway, Suite 216, Columbia, MD 21045, serving Columbia, Howard County, Ellicott City, Fulton, and surrounding Maryland communities. Our physicians evaluate men's hormone concerns at the Columbia clinic, review blood work, and discuss whether therapy is appropriate and how it will be monitored. Call (443) 917-6500 or book a consultation to talk through your symptoms and labs.

Explore men's hormone therapy at Zest Regen Health

Read the full guide to testosterone therapy: what patients should know

Learn the signs of low testosterone in men

Meet our physicians, who evaluate men's hormone concerns at the Columbia clinic

Next step

If low testosterone symptoms are affecting your energy, mood, or quality of life, the first step is evaluation, not a prescription. Book a free 15-minute consultation at the Columbia clinic to review your symptoms, get the right testing, and understand what the current evidence actually supports.