Editorial
Written byMen's Health Istanbul Editorial Team
Medical reviewProf. Dr. Ege Can Şerefoğlu
Last medical reviewAwaiting reviewer sign-off
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 does not show that testosterone is safe or useful for men with normal levels.
What happened?
Earlier, smaller studies had given conflicting signals about whether testosterone treatment might increase the risk of heart attack and stroke. Regulators asked for a proper test. The result was TRAVERSE, a randomised trial published in the New England Journal of Medicine in 2023.
The trial 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. They were randomly assigned to a daily testosterone gel or a placebo gel, and followed for major cardiac events.
What the research actually shows
The study found that testosterone treatment was non-inferior to placebo for major adverse cardiac events: the rate of heart attack, stroke and cardiovascular death was not meaningfully higher in the testosterone group. For this specific group of men, that removed one of the main safety concerns.
The trial also reported that atrial fibrillation (an irregular heart rhythm), acute kidney injury and pulmonary embolism (a blood clot in the lungs) occurred more often in men taking testosterone. Many participants stopped their treatment before the end of the study, which is a common limitation of long trials.
What does this mean for patients?
For men with a genuinely confirmed deficiency and a clear reason for treatment, TRAVERSE offers useful reassurance about heart attack and stroke risk. The decision still needs an individual assessment, including a discussion of the other risks the trial reported, fertility plans and regular monitoring.
What should not be concluded
- 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. Other side effects, including suppression of sperm production, remain.
For background on how levels change with age, read Does testosterone naturally decline after 40?
References
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. N Engl J Med. 2023;389(2):107–117. Source
- Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol. 2018;200(2):423–432.
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.
