Does Testosterone Therapy Raise Heart Risk? What The TRAVERSE Trial Found
For years, the big question hanging over testosterone therapy was whether it raises the risk of heart attack and stroke. A large placebo-controlled trial published in 2023 was built to answer it, and the FDA has since changed the labels. Here's what it showed and what it didn't settle.
Why The Question Came Up
In 2015, the FDA required testosterone labels to warn about a possible increased risk of heart attack and stroke. At the time the evidence was mixed: some studies had reported a higher risk with testosterone treatment and others hadn't. TRAVERSE is the large placebo-controlled trial that followed.
What TRAVERSE Tested
TRAVERSE, published in the New England Journal of Medicine in 2023, enrolled 5,246 men aged 45 to 80 who had symptoms of low testosterone, two fasting testosterone levels below 300 ng/dL, and either existing heart disease or a high risk of it. They used a daily 1.62% testosterone gel, adjusted to keep levels within a set range, or a placebo gel, and were followed for about 33 months on average.
What It Found
Heart attack, stroke, or death from cardiovascular causes happened in 7.0% of the testosterone group and 7.3% of the placebo group. That met the trial's test for showing testosterone was not worse than placebo on these events. The testosterone group did have more atrial fibrillation (an irregular heart rhythm), acute kidney injury, and pulmonary embolism (a blood clot in the lungs). Get emergency care for chest pain, sudden shortness of breath, pain or swelling in one leg, or a racing or irregular heartbeat.
What The FDA Changed
In February 2025, after reviewing TRAVERSE, the FDA recommended adding its results to all testosterone labels and removing language from the boxed warning about an increased risk of adverse cardiovascular outcomes. At the same time, blood pressure studies the FDA had required confirmed that testosterone raises blood pressure across the whole class, so the agency required a blood pressure warning on every testosterone product that didn't already carry one, which is a good reason to keep an eye on your blood pressure while you're on treatment. In June 2026, the FDA asked for further label updates, including revised safety information on prostate cancer and enlarged prostate, so the labels are still changing.
What It Didn't Settle
TRAVERSE studied one FDA-approved gel in men 45 and older with confirmed low testosterone. It doesn't tell you about injections, creams, younger men, or men whose levels aren't low. The testosterone cream and injection offered through Osirius are compounded, which means they are not FDA-approved and the FDA has not evaluated them for safety or effectiveness. The other known risks still apply. The Endocrine Society's 2018 guideline advises pausing testosterone if hematocrit rises above 54% until it comes down, current labeling says it shouldn't be used by men with breast cancer or known or suspected prostate cancer, and the AUA advises against it for men trying to conceive. Our guide to testosterone injections vs. cream covers monitoring.
Where To Start
A licensed provider reviews your heart history, blood pressure, current medications, and labs, and decides whether testosterone therapy fits. Low testosterone should be confirmed with more than one morning blood test first; our guide to testosterone lab numbers explains why. If you have heart disease or have ever had a blood clot, say so up front.
This guide explains general information and is not medical advice. It doesn't replace a licensed provider reviewing your own history.