TRAVERSE Trial: Cardiovascular Safety of Testosterone-Replacement Therapy (NEJM)

Tier 1: Established: peer-reviewed research or government health authority
Publisher: New England Journal of Medicine · Published: August 21, 2026 · Accessed: August 21, 2026

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Claims this source supports

• TRAVERSE enrolled 5,246 men aged 45-80 with symptoms of hypogonadism, two fasting testosterone levels below 300 ng/dL, and preexisting cardiovascular disease or high cardiovascular risk; participants were randomized to daily transdermal 1.62% testosterone gel or placebo.
• Over a median follow-up of about 3 years, testosterone replacement therapy was noninferior to placebo for major adverse cardiac events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke).
• The testosterone group had higher rates of pulmonary embolism, atrial fibrillation, and acute kidney injury, showing the therapy carries real risks even when cardiovascular outcomes are not worse.
• TRAVERSE results apply to men with verified hypogonadism (two fasting levels below 300 ng/dL) and cardiovascular risk factors – not to the general midlife male population, and not to self-diagnosed 'male menopause.'