TRAVERSE: testosterone does not raise major cardiac events in men with hypogonadism
In 5,246 men aged 45 to 80 with low testosterone and existing or high risk of cardiovascular disease, testosterone gel was noninferior to placebo for heart attack, stroke and cardiovascular death.
EVIDENCE:
Human RCT
WHY IT MATTERS
It settled a decade of uncertainty after earlier observational studies raised alarms, and the FDA updated testosterone labels in 2025 to reflect the results. It does not make testosterone risk-free or appropriate for men without true deficiency.
Major adverse cardiac events occurred in 7.0% of men on testosterone and 7.3% on placebo (hazard ratio 0.96). Atrial fibrillation, acute kidney injury and pulmonary embolism were more frequent with testosterone.
A 2024 fracture substudy unexpectedly found more clinical fractures in the testosterone group (3.5% vs 2.5%). Diagnosis still requires symptoms plus consistently low early-morning levels, and men who want to preserve fertility need a different approach because testosterone suppresses sperm production.
PRIMARY SOURCE
Lincoff AM et al. N Engl J Med 2023;389:107–117
TRAVERSE · NCT03518034
Educational summary reviewed by Farhan Tahir, MD. Not individual medical advice. Medicines named here require a prescription and medical supervision.
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TRAVERSE: testosterone does not raise major cardiac events in men with hypogonadism
In 5,246 men aged 45 to 80 with low testosterone and existing or high risk of cardiovascular disease, testosterone gel was noninferior to placebo for heart attack, stroke and cardiovascular death.
Human RCT