TRAVERSE tested whether testosterone treatment raised the rate of cardiovascular death, heart attack or stroke in men with hypogonadism and existing or high heart risk. The TRAVERSE trial report found testosterone met its test for noninferiority on that outcome, while atrial fibrillation, acute kidney injury and pulmonary embolism were more frequent with testosterone. The trial used a daily 1.62% testosterone gel, not testosterone cypionate injection.
Who was in the trial
The TRAVERSE report describes a multicenter, randomized, double-blind, placebo-controlled noninferiority trial of 5,246 men aged 45 to 80. Each man had existing or high risk of cardiovascular disease, symptoms of hypogonadism, and two fasting testosterone levels below 300 ng/dL. Men were given daily 1.62% testosterone gel or a placebo gel.
Mean treatment was 21.7 months and mean follow-up was 33.0 months. A noninferiority design asks whether a treatment is not meaningfully worse than placebo on the main outcome. It is not built to show that a treatment protects the heart.
The main heart result
The primary endpoint combined cardiovascular death, nonfatal heart attack and nonfatal stroke. It occurred in 7.0% of men on testosterone and 7.3% on placebo (hazard ratio 0.96, 95% CI 0.78 to 1.17), which met the trial's noninferiority test.
Risks that were more common with testosterone
The prescribing information for Aveed, a long-acting testosterone undecanoate injection, summarizes TRAVERSE results for the gel. It is not the cypionate label. The figures it reports are below.
| Outcome in TRAVERSE | Testosterone gel | Placebo |
|---|---|---|
| Nonfatal arrhythmias warranting intervention | 5.2% | 3.3% |
| Atrial fibrillation | 3.5% | 2.4% |
| Acute kidney injury | 2.3% | 1.5% |
| Bone fracture | 3.5% | 2.5% |
| Venous thromboembolism (numerically higher) | 1.7% | 1.2% |
| Pulmonary embolism | 0.9% | 0.5% |
| Deep vein thrombosis | 0.6% | 0.5% |
The same Aveed prescribing information reports that mean systolic blood pressure rose 1.0 mm Hg on testosterone gel at 36 months and fell 0.5 mm Hg on placebo, a 1.5 mm Hg difference. It also says about 61% of all patients discontinued gel or placebo.
In the TRAVERSE fracture subtrial of 5,204 men, with median follow-up of 3.19 years, clinical fractures occurred in 3.50% on testosterone and 2.46% on placebo (hazard ratio 1.43, 95% CI 1.04 to 1.97). Testosterone did not lower fracture incidence.
A 2024 review of the prostate data says that among men screened to exclude high prostate cancer risk, rates of high-grade or any prostate cancer and other prostate events were low and did not differ from placebo. PSA rose more on testosterone in the first year.
What the FDA did after TRAVERSE
On February 28, 2025, the FDA announced class-wide labeling changes. It said TRAVERSE results would be added to all testosterone labels, Boxed Warning language on increased cardiovascular risk would be removed, and the Limitation of Use for age-related hypogonadism would stay. The same announcement said completed ambulatory blood pressure monitoring studies confirmed a blood pressure increase with all testosterone products class-wide, and it required a blood pressure warning for products lacking one.
The FDA's Testosterone Information page, current as of 06/23/2026, says the FDA requested label updates in June 2026. These include removing the age-related hypogonadism limitation of use and revising prostate cancer and BPH safety information. In the labels read for this guide, the current Depo-Testosterone label and a generic cypionate label revised June 2026 still state that safety and efficacy in age-related hypogonadism have not been established.
What this does not tell you
TRAVERSE tested a daily gel. It does not directly show how testosterone cypionate injections into muscle affect the heart. It enrolled men aged 45 to 80 with heart risk, so it does not describe younger men or men without that risk.
Mean treatment was 21.7 months and about 61% of patients stopped gel or placebo, so it does not settle effects over many years. The prostate findings come from men screened to exclude high prostate cancer risk. Meeting noninferiority is not proof of heart benefit. A licensed provider weighs these results for each man.