Testosterone and Heart Health: What the TRAVERSE Trial Revealed
For over a decade, the relationship between testosterone and cardiovascular health has been surrounded by confusion. A handful of publicized studies suggested that testosterone therapy might increase heart attack and stroke risk, and regulators and doctors became cautious. Then, in 2023, the largest randomized trial on the question was published, and it changed the conversation, though it did not make the question simple.
Key takeaways
- In TRAVERSE (5,246 men aged 45 to 80 with low testosterone and preexisting or high risk of cardiovascular disease), major cardiac events occurred in 7.0% of the testosterone group and 7.3% of the placebo group (hazard ratio 0.96; 95% CI 0.78 to 1.17), meeting the noninferiority goal.[1]
- Testosterone was not risk-free: atrial fibrillation, acute kidney injury, and pulmonary embolism were more frequent in the testosterone group.[1]
- Observational studies link low testosterone with higher cardiovascular and all-cause mortality, but the studies differ widely, and low testosterone may partly reflect poor general health.[2,3]
- After TRAVERSE, the FDA removed boxed-warning language about increased cardiovascular risk from testosterone labels, while adding a warning about increased blood pressure.[4]
The TRAVERSE Trial: A Turning Point
The TRAVERSE (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men) trial was published in the New England Journal of Medicine in 2023 by Lincoff and colleagues. It was designed to test whether testosterone replacement therapy is noninferior to placebo for cardiovascular safety.[1]
The trial enrolled 5,246 men aged 45 to 80 who had preexisting or a high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels below 300 ng/dL. They were randomly assigned in a double-blind design to daily 1.62% testosterone gel (dose adjusted to maintain levels between 350 and 750 ng/dL) or placebo gel. Mean treatment duration was about 21.7 months, and mean follow-up was about 33 months.[1]
The primary endpoint was the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. It occurred in 182 men (7.0%) in the testosterone group and 190 men (7.3%) in the placebo group (hazard ratio 0.96; 95% CI 0.78 to 1.17), which met the prespecified noninferiority margin. Secondary cardiovascular outcomes also appeared similar between groups.[1]
What TRAVERSE Does Not Say
TRAVERSE does not show that testosterone is risk-free. The authors reported a higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.[1] It enrolled men with symptoms and confirmed low testosterone, used one gel formulation at dose-adjusted levels, and lasted a few years, so it does not tell us about men with normal testosterone, other formulations, higher doses, or very long-term use. The trial was funded by AbbVie and others. Testosterone therapy should only be started and monitored by a doctor.
Why Earlier Studies Raised Concern
Earlier signals came from studies with important limitations:
- The 2010 TOM trial enrolled 209 men (mean age 74) with limited mobility and a high prevalence of chronic disease. It was stopped early because of more cardiovascular-related adverse events in the testosterone group (23 versus 5 subjects). Its authors noted that the small size and unique population prevented broader inferences.[5]
- A 2013 retrospective Veterans Affairs cohort study (published with a correction) reported higher event rates among men with low testosterone who started therapy. Observational designs like this cannot fully separate the effect of the drug from differences between the men who receive it.[6]
- A 2014 claims-database analysis found a higher rate of nonfatal heart attack in the 90 days after an initial testosterone prescription than in the prior year, particularly in older men and in younger men with heart disease. Again, this was observational.[7]
TRAVERSE was a randomized, placebo-controlled trial designed for this question, which is why it carries more weight on cardiovascular outcomes in the population it studied.
Low Testosterone and Cardiovascular Risk
Separately from the safety of therapy, researchers have asked whether low natural testosterone is itself a risk marker. A systematic review of observational studies found that low endogenous testosterone was associated with increased risk of all-cause and cardiovascular death in community-based studies of men, but with considerable heterogeneity that the authors suggested may reflect differences in underlying health status.[2]
A meta-analysis of prospective studies in healthy men found a weak overall association between lower testosterone and cardiovascular disease. There was no association in men younger than 70, and a weak one in older men, leading the authors to note that low testosterone may simply indicate poor general health.[3]
Observational data cannot establish causation. Obesity, diabetes, and chronic illness can lower testosterone and independently raise cardiovascular risk. Excess body fat and testosterone appear to influence each other in both directions, which is one reason healthy weight is a shared target for hormones and heart health.
Is There an Optimal Range for Heart Health?
No optimal testosterone level for heart health has been established by trial evidence. In TRAVERSE, the dose was adjusted to keep levels between 350 and 750 ng/dL.[1] In practice, the Endocrine Society suggests aiming for mid-normal levels when testosterone therapy is prescribed.[8]
At the other extreme, illicit anabolic-androgenic steroid use at doses far above physiological has been associated with harm. In a cross-sectional study of 140 experienced weightlifters, men who had used these steroids for two or more years had lower left ventricular ejection fraction (52% versus 63%) and higher coronary plaque volume than nonusers.[9] The goal of a health-focused approach is a normal, healthy range under medical supervision, not maximization.
Exercise: Where Hormone and Heart Health Overlap
Exercise is good for the heart regardless of what it does to testosterone. The World Health Organization recommends that adults do 150 to 300 minutes of moderate-intensity (or 75 to 150 minutes of vigorous-intensity) aerobic activity per week, plus regular muscle-strengthening activity.[10]
✓ Habits that support heart and general health
- •Meeting weekly aerobic activity guidelines
- •Regular muscle-strengthening exercise
- •Maintaining a healthy body weight
- •Consistent, adequate sleep
- •Managing chronic stress
✗ Habits associated with higher risk
- •A sedentary lifestyle
- •Excess body fat, especially around the abdomen
- •Untreated sleep apnea or chronic sleep loss
- •Illicit anabolic steroid use
- •Skipping routine blood pressure and cholesterol checks
Combining resistance training and aerobic exercise is a sensible way to meet both sets of guidelines. See HIIT vs weight training for testosterone for how the two compare.
Statins and Testosterone
Statins are widely prescribed to lower cholesterol, and cholesterol is a precursor to steroid hormones. A meta-analysis of randomized trials found that in 5 trials of 501 mainly middle-aged men with hypercholesterolemia, statins lowered testosterone by about 0.66 nmol/L on average.[11] The clinical meaning of that small change is unclear. If you take a statin, do not stop it on your own; discuss any concerns about testosterone with your prescribing doctor.
Questions to Raise With Your Doctor
Heart-Related Topics to Discuss
Low testosterone symptoms plus metabolic risk
Low energy, low libido, increased belly fat, and rising blood sugar overlap with both low testosterone and cardiovascular risk. Ask your doctor about a full assessment, including repeat morning testosterone, blood pressure, lipids, and glucose.
Blood tests and blood pressure if on testosterone therapy
The Endocrine Society guideline advises evaluating men who develop erythrocytosis (hematocrit above 54%) and withholding therapy until it normalizes. FDA labeling now includes warnings about increased blood pressure, so blood pressure monitoring matters during therapy.
Family history and personal risk factors
If close relatives had early heart disease, or you have high blood pressure, high cholesterol, diabetes, or smoke, tell your doctor. These factors matter more for your heart than testosterone alone.
Sleep apnea symptoms
Loud snoring, witnessed breathing pauses, and daytime sleepiness warrant a conversation. The American Heart Association notes that sleep apnea is underrecognized in cardiovascular practice. See our guide on sleep apnea and testosterone.
These points draw on the Endocrine Society guideline, FDA labeling changes, and an American Heart Association scientific statement.[8,4,12] For more, see sleep apnea and testosterone.
The Bottom Line
TRAVERSE showed that, in symptomatic men with low testosterone and cardiovascular risk, testosterone gel was noninferior to placebo for major cardiac events over about three years, with some other safety signals to watch. Observational data link low testosterone with worse outcomes, but cannot show that raising it would help the heart. For most men, the practical overlap is in lifestyle: regular exercise, good sleep, healthy weight, stress management, and routine checkups.
This article is educational and not medical advice. Decisions about testing or testosterone therapy should be made with your doctor.
Related Reading
- How to Increase Testosterone Naturally: lifestyle approaches that also support general health.
- The Complete T-Maxing Guide: the full habit stack for long-term health.
How Thrive Helps
Thrive tracks the daily habits that research connects to both hormone health and cardiovascular wellness: training consistency, sleep quality, stress management, nutrition, and body composition indicators. Every habit carries an evidence grade showing how strong the research is behind it. Try Thrive free. Thrive is a wellness app and not a medical device; it does not diagnose or treat any condition.
References
- Lincoff AM, Bhasin S, Flevaris P, et al.. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023. doi.org/10.1056/NEJMoa2215025
- Araujo AB, Dixon JM, Suarez EA, et al.. Clinical review: Endogenous testosterone and mortality in men: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2011. doi.org/10.1210/jc.2011-1137
- Ruige JB, Mahmoud AM, De Bacquer D, Kaufman JM. Endogenous testosterone and cardiovascular disease in healthy men: a meta-analysis. Heart. 2011. doi.org/10.1136/hrt.2010.210757
- U.S. Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. FDA Drug Safety Communication. 2025. www.fda.gov/drugs/drug-alerts-and-statements/fda-issues-class-wide-labeling-changes-testosterone-products
- Basaria S, Coviello AD, Travison TG, et al.. Adverse events associated with testosterone administration. N Engl J Med. 2010. doi.org/10.1056/NEJMoa1000485
- Vigen R, O'Donnell CI, Baron AE, et al.. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013. doi.org/10.1001/jama.2013.280386
- Finkle WD, Greenland S, Ridgeway GK, et al.. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014. doi.org/10.1371/journal.pone.0085805
- Bhasin S, Brito JP, Cunningham GR, et al.. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018. doi.org/10.1210/jc.2018-00229
- Baggish AL, Weiner RB, Kanayama G, et al.. Cardiovascular Toxicity of Illicit Anabolic-Androgenic Steroid Use. Circulation. 2017. doi.org/10.1161/CIRCULATIONAHA.116.026945
- Bull FC, Al-Ansari SS, Biddle S, et al.. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020. doi.org/10.1136/bjsports-2020-102955
- Schooling CM, Au Yeung SL, Freeman G, Cowling BJ. The effect of statins on testosterone in men and women, a systematic review and meta-analysis of randomized controlled trials. BMC Med. 2013. doi.org/10.1186/1741-7015-11-57
- Yeghiazarians Y, Jneid H, Tietjens JR, et al.. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021. doi.org/10.1161/CIR.0000000000000988