Editorial
Written byMen's Health Istanbul Editorial Team
Medical reviewer (awaiting sign-off)Prof. Dr. Ateş Kadıoğlu
Published
Updated
Medically reviewedNot yet
The short answer
The TRAVERSE trial, published in 2023, found that testosterone gel did not increase the rate of heart attack, stroke or cardiovascular death compared with a placebo gel in men aged 45 to 80 who had low testosterone and existing heart disease or a high risk of it. That is reassuring for men with a confirmed deficiency who need treatment. However, atrial fibrillation, acute kidney injury and blood clots in the lungs were more common with testosterone, and the trial says nothing about men with normal levels or about non-prescribed use.
Key takeaways
- TRAVERSE was a randomised, placebo-controlled trial in 5,246 men aged 45 to 80 with low testosterone and existing heart disease or a high risk of it.
- Testosterone gel did not increase the rate of major cardiac events (heart attack, stroke or cardiovascular death) compared with placebo.
- Some other problems, including atrial fibrillation, acute kidney injury and blood clots in the lungs, were more common with testosterone.
- The trial tells us nothing about benefits or risks for men with normal testosterone levels.
The question
Does testosterone treatment increase the risk of heart attack and stroke in men with low testosterone? Earlier, smaller studies had given conflicting signals, and for years doctors and patients were unsure. Regulators asked for a proper test.
The study
The answer was TRAVERSE, a randomised, placebo-controlled trial published in the New England Journal of Medicine in 2023. It enrolled 5,246 men aged 45 to 80 who had symptoms of low testosterone, repeatedly low blood levels and either existing cardiovascular disease or a high risk of it.
The men were randomly assigned to a daily testosterone gel or a placebo gel, and followed for major adverse cardiac events: heart attack, stroke and death from cardiovascular causes.
What they found
Testosterone treatment was non-inferior to placebo for major adverse cardiac events. In other words, the rate of heart attack, stroke and cardiovascular death was not meaningfully higher in the testosterone group.
Some other problems were more common in men taking testosterone: atrial fibrillation (an irregular heart rhythm), acute kidney injury and pulmonary embolism (a blood clot in the lungs). Many participants stopped their treatment before the end of the study, a common limitation of long trials.
What it does NOT prove
- It does not show that testosterone protects the heart.
- It does not apply to men with normal testosterone, or to high-dose or non-prescribed use.
- It does not mean testosterone is free of risk. The other problems above, and suppression of sperm production, remain.
Why it matters
For men with a genuinely confirmed deficiency and a clear reason for treatment, TRAVERSE removes one of the main concerns about heart attack and stroke. The decision still needs an individual assessment, including a discussion of the other risks the trial reported, fertility plans and regular monitoring.
For background on how levels change with age, read Does testosterone naturally decline after 40?
Questions men also ask
Does testosterone therapy cause heart attacks?
In TRAVERSE, men with low testosterone and heart risk who used testosterone gel did not have more heart attacks, strokes or cardiovascular deaths than men using placebo. The result applies to that group, not to everyone.
Do the TRAVERSE results apply to men with normal testosterone?
No. Everyone in the trial had symptoms and confirmed low testosterone, so the findings cannot be applied to men with normal levels or to high-dose use.
Sources & further reading
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. N Engl J Med. 2023;389(2):107–117. View source (opens in a new tab)
- Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol. 2018;200(2):423–432.
Concerned about something you've read?
Ask one of our specialists privately. There is no obligation, and no question is too awkward.
This article is general health information. It does not replace an individual medical consultation, examination or diagnosis. Read our editorial policy and medical review policy.
