Testosterone and Cardiovascular Health: What the Latest Research Shows

For almost a decade, a shadow hung over testosterone replacement therapy a fear, embedded in FDA black box warnings and cautionary headlines, that TRT raised the risk of heart attacks and strokes. Men who needed treatment hesitated. Physicians who might have prescribed held back. And countless men with documented hypogonadism went untreated, with real consequences for their energy, mood, body composition, bone density, and sexual function.

In February 2025, the FDA updated the prescribing labels for all testosterone replacement products. The black box cardiovascular warning was removed. The agency’s reassessment was grounded in the most robust clinical evidence ever generated on this question: the landmark TRAVERSE trial, which enrolled 5,246 men in the largest randomized controlled trial of TRT cardiovascular safety ever conducted.

The science has moved. It’s time the conversation catches up.

Where the Fear Started and Why It Was Always Complicated

The concern about testosterone and cardiovascular health didn’t appear from nowhere. Two studies, published in 2010 and 2013, showed increased cardiovascular events in men receiving testosterone results alarming enough that the FDA added a black box warning in 2015 requiring all TRT products to carry language about potential cardiovascular risk.

But those studies had significant methodological problems. Both were small, used non standard dosing, and included populations with extreme baseline cardiovascular risk. Neither was a randomized controlled trial designed specifically to answer the cardiovascular safety question.

Meanwhile, the physiological evidence was pointing in the opposite direction. Low testosterone is consistently associated with central obesity, insulin resistance, dyslipidemia, type 2 diabetes, hypertension, and endothelial dysfunction all established cardiovascular risk factors. The biological logic was: men with low testosterone have worse metabolic health, and worse metabolic health drives heart disease. The question was never whether low testosterone was bad for the heart. It clearly is. The question was whether replacing testosterone in hypogonadal men helped, harmed, or made no difference to cardiovascular outcomes.

The connection between declining testosterone and broader health decline is foundational to understanding why this research matters beyond just TRT patients.

The TRAVERSE Trial: The Definitive Answer

TRAVERSE the Testosterone Replacement Therapy on the Incidence of Major Adverse Cardiovascular Events and Efficacy Measures in Hypogonadal Men trial was designed specifically to resolve the cardiovascular safety question with Level 1 evidence.

The trial enrolled 5,246 men ages 45–80 with documented hypogonadism (two fasting testosterone levels below 10.4 nmol/L), confirmed symptoms, and either pre existing cardiovascular disease or high cardiovascular risk. These were not healthy, low risk young men. This was the population about whom the safety concerns were most acute.

Primary findings (published in NEJM, June 2023):

• Major adverse cardiovascular events (MACE the composite of heart attack, stroke, and cardiovascular death) occurred in 7.0% of the testosterone group vs. 7.3% of the placebo group
• This difference was not statistically significant, establishing that TRT was non inferior to placebo for cardiovascular events in high risk hypogonadal men
• There were 16 fewer deaths in the testosterone group a small, non significant reduction, but in the right direction
• The testosterone group showed significantly improved HbA1c in men with prediabetes and diabetes at baseline meaning better metabolic outcomes alongside cardiac safety

The April 2025 review in World Journal of Men’s Health confirmed the interpretation: TRAVERSE definitively addressed the cardiovascular safety concerns that had clouded the field for nearly a decade.

In January 2026, a European Expert Panel position statement published in Andrology reached the same conclusion: TRT, when prescribed to appropriately selected patients and monitored regularly, is safe from a cardiovascular standpoint and the potential benefits outweigh the risks when therapy is used appropriately. The European Medicines Agency had already reached a similar conclusion years earlier, finding no consistent evidence that testosterone products increase cardiovascular risk.

The February 2025 FDA Label Update: What Actually Changed

The FDA’s February 2025 update to testosterone prescribing information is clinically significant and it’s worth being precise about what changed and what didn’t.

What was removed: The black box warning language suggesting a potential increase in risk of heart attack and stroke with testosterone use was eliminated from all FDA approved TRT products.

What remained: The FDA retained the “Limitation of Use” statement testosterone is not FDA approved for age related testosterone decline in otherwise healthy men. The indication remains hypogonadism: a documented medical condition with symptoms and confirmed low testosterone levels on two separate measurements.

What was updated: New blood pressure monitoring guidance was added TRT can modestly increase blood pressure in some men, and this requires monitoring. Hematocrit (red blood cell concentration) monitoring requirements were also updated, reflecting that testosterone raises red blood cell production, which requires periodic surveillance in men on long term therapy.

The practical implication: TRT is not a cardiovascular risk for appropriately selected and monitored hypogonadal men. It is not approved as a performance enhancer, anti aging therapy, or treatment for normal age related testosterone decline and using it outside that framework changes the risk benefit calculation.

Low Testosterone as a Cardiovascular Risk Factor

This is the part of the testosterone and cardiovascular health conversation that rarely gets adequate attention: the risks of untreated low testosterone.

A growing body of evidence, including large observational studies and the secondary analyses from TRAVERSE itself, shows that hypogonadal men with untreated low testosterone have:

• Higher rates of visceral obesity and metabolic syndrome
• Greater prevalence of type 2 diabetes and insulin resistance
• Higher blood pressure and adverse lipid profiles
• Increased arterial stiffness and endothelial dysfunction
• Higher all cause mortality compared to eugonadal men

The TRAVERSE trial found that men on TRT showed measurably better metabolic outcomes particularly improved HbA1c in those with prediabetes or diabetes compared to placebo. This is not a trivial finding. Insulin resistance is a primary driver of cardiovascular risk, and any intervention that improves insulin sensitivity without increasing cardiac events is clinically meaningful.

Low testosterone and depression compound this picture depression is itself an independent cardiovascular risk factor, and hypogonadal men carry elevated rates of both.

What This Means for Monitoring and Clinical Management

The TRAVERSE data and February 2025 FDA update don’t suggest TRT is risk free they suggest it is appropriate for the right patient, managed correctly. For men (and for women navigating hormonal health, where testosterone plays a role too), here is what responsible clinical management actually looks like:

Before starting TRT:

• Confirm diagnosis with two separate fasting testosterone measurements (total and free)
• Establish baseline: complete blood count (hematocrit/hemoglobin), lipid panel, blood pressure, PSA, and comprehensive metabolic panel
• Evaluate for cardiovascular risk factors that may require treatment alongside TRT
• Understand the full picture of what a hormone panel tests for

During TRT:

• Blood pressure monitoring, particularly in the first 3–6 months
• Hematocrit monitoring every 3–6 months dose adjustment or therapeutic phlebotomy if hematocrit exceeds 54%
• PSA monitoring (annually for men 40 and older)
• Testosterone levels (total and free) every 6–12 months to confirm target range
• Annual assessment of metabolic markers reading your blood test results clearly ensures nothing slips through

For men considering TRT who haven’t yet started, the question of enclomiphene versus traditional TRT is worth understanding particularly for younger men with fertility considerations, where stimulating endogenous production is preferable to exogenous replacement. And for men on TRT who want to understand its implications for fertility, TRT and fertility covers that specifically.

Conclusion: The Evidence Has Arrived Now Act On It

Testosterone and cardiovascular health is no longer a debate characterized by conflicting small studies and regulatory uncertainty. The TRAVERSE trial enrolled more participants than any prior cardiovascular TRT trial, followed them longer, and answered the primary question with confidence: TRT does not increase major adverse cardiovascular events in hypogonadal men with pre existing or high cardiovascular risk.

The FDA updated its labels. The European Expert Panel issued a formal position statement. The clinical community has largely reached consensus.

What hasn’t changed: TRT requires proper diagnosis, appropriate patient selection, and consistent monitoring. The hormone isn’t the risk. The lack of clinical oversight is.

At AK Twisted Wellness, we provide comprehensive testosterone evaluations and ongoing monitoring via telehealth covering the full hormonal and metabolic picture that turns a prescription into a protocol. We don’t just check a box; we track your hematocrit, blood pressure, PSA, and metabolic markers alongside your testosterone levels to make sure the treatment is working the way it should.

Visit aktw.life or call (520) 710 8805. Telehealth available nationwide.

Frequently Asked Questions

1. Does testosterone replacement therapy increase the risk of heart attack? Based on the most current evidence including the TRAVERSE trial (5,246 men, published in NEJM) and the FDA’s February 2025 label update TRT does not increase the risk of major adverse cardiovascular events (heart attack, stroke, cardiovascular death) in appropriately selected men with documented hypogonadism. The FDA removed the previous black box cardiovascular warning from all TRT products in February 2025, reflecting this evidence.

2. What was the TRAVERSE trial and why does it matter? TRAVERSE was the largest randomized, double blind, placebo controlled trial of testosterone replacement therapy ever conducted enrolling 5,246 men ages 45–80 with documented hypogonadism and pre existing or high cardiovascular risk. It was specifically designed to answer the cardiovascular safety question definitively. The primary finding was that TRT was non inferior to placebo for major adverse cardiovascular events (7.0% vs. 7.3%), clearing the major concern that had limited testosterone prescribing for nearly a decade.

3. Is low testosterone itself a cardiovascular risk factor? Yes significant evidence links low testosterone to visceral obesity, metabolic syndrome, insulin resistance, elevated blood pressure, adverse lipid profiles, and higher all cause mortality. Hypogonadal men consistently show worse cardiometabolic profiles than their eugonadal counterparts, and TRAVERSE found that TRT improved HbA1c in men with prediabetes and diabetes. Untreated low testosterone is not metabolically neutral it carries its own risk burden.

4. What monitoring is required during testosterone therapy? The February 2025 FDA label update specifically requires blood pressure monitoring on TRT, given evidence that testosterone can modestly raise blood pressure in some men. Hematocrit monitoring every 3–6 months is also required, as TRT raises red blood cell production and elevated hematocrit (above 54%) increases clotting risk. PSA, testosterone levels, and a comprehensive metabolic panel should be checked regularly as part of ongoing TRT management.

5. Can women have cardiovascular issues from low testosterone? Women produce testosterone in smaller amounts than men, and it plays a meaningful role in metabolic health, energy, bone density, and libido in women as well. Low testosterone in women particularly common in perimenopause and menopause is associated with increased visceral fat accumulation and metabolic dysfunction, which carry cardiovascular implications. Women considering hormone therapy should have a complete hormonal evaluation that includes testosterone, estradiol, and relevant metabolic markers. HRT options for women and the relationship between perimenopause and metabolic health provide important context.

6. How does AK Twisted Wellness manage testosterone and cardiovascular health monitoring? We treat TRT as a medically managed protocol not just a prescription. Before starting, we confirm diagnosis with two separate testosterone measurements and establish a full baseline including hematocrit, lipid panel, blood pressure, PSA, and metabolic markers. During therapy, we monitor all relevant safety parameters on a structured schedule and adjust protocols based on your individual response. Our telehealth platform means this oversight happens continuously, not just at an annual visit. Visit aktw.life or call (520) 710 8805.

References

1. Lincoff, A.M., Bhasin, S., Flevaris, P., et al. (2023). Cardiovascular Safety of Testosterone Replacement Therapy. New England Journal of Medicine, 389, 107–117. https://www.nejm.org/doi/full/10.1056/NEJMoa2215025
2. Hackett, G.I. (2025). Long Term Cardiovascular Safety of Testosterone Therapy: A Review of the TRAVERSE Study. World Journal of Men’s Health, 43(2), 282–290. https://pmc.ncbi.nlm.nih.gov/articles/PMC11937349/
3. Zitzmann, M., Rastrelli, G., Murray, R.D., et al. (2026). Cardiovascular Safety of Testosterone Therapy Insights from the TRAVERSE Trial and Beyond: A Position Statement of the European Expert Panel for Testosterone Research. Andrology, 14(1), 294–302. https://pmc.ncbi.nlm.nih.gov/articles/PMC12670475/
4. Walia, H. (2025). Testosterone Replacement, Where Are We in 2025? Trends in Urology & Men’s Health. https://onlinelibrary.wiley.com/doi/10.1002/tre.70016
5. Cleveland Clinic / ConsultQD. (2025). TRAVERSE Study Supports Cardiovascular Safety of Testosterone Therapy When Used as Indicated. https://consultqd.clevelandclinic.org/traverse study supports cardiovascular safety of testosterone therapy when used as indicated
6. U.S. Food & Drug Administration. (2025). FDA Updates Testosterone Prescribing Labels February 2025 Drug Safety Communication. https://www.fda.gov/drugs/drug safety and availability/fda drug safety communication fda cautions about using testosterone products low testosterone due
7. Superior Health & Wellness Clinic. (2025). FDA Confirms TRAVERSE Results: Black Box Warning Removed from TRT Labels. https://yoursuperiorwellness.com/weve been saying it now the fda confirms it/
8. American Urological Association. (2025). Male Hypogonadism Clinical Guidelines Cardiovascular Monitoring Recommendations. https://www.auanet.org/guidelines and quality/guidelines/male hypogonadism guideline
9. European Medicines Agency. (2014/Updated 2024). No Consistent Evidence of Increased Risk of Heart Problems with Testosterone Medicines. https://www.ema.europa.eu/en/documents/press release/no consistent evidence increased risk heart problems testosterone medicines_en.pdf
10. Pencina, K.M., Lincoff, A.M., Klein, E.A., et al. (2025). Testosterone Replacement Therapy and Risk of COVID 19 and Effect on Treatment Outcomes. Journal of the Endocrine Society, 9(3), bvaf002. https://pubmed.ncbi.nlm.nih.gov/40372318/
    

Disclaimer: This content is for informational and educational purposes only and does not constitute medical, legal, or financial advice. Reading this article does not create a patient provider relationship. Testosterone replacement therapy requires proper medical diagnosis, individualized evaluation, and ongoing clinical monitoring never start, stop, or adjust any hormone therapy without guidance from a qualified healthcare provider. For questions about AK Twisted Wellness services, visit aktw.life or call (520) 710 8805.