The current cardiovascular discussion about TRT has two important parts: a major trial provided reassurance about certain cardiovascular outcomes in a defined population, while the FDA also required new or expanded blood-pressure warnings. Neither part should be omitted. Testosterone treatment still needs a supported diagnosis, an individual cardiovascular assessment, and follow-up. This guide explains what TRAVERSE studied, what the 2025 FDA update changed, and why blood pressure remains relevant even when a headline says a boxed warning was removed.
Start with the reason testosterone is being prescribed
TRT is considered for men with compatible symptoms or signs and consistently low testosterone, after evaluation of the cause. It is not a general heart-health treatment. A low result during illness or an isolated symptom such as fatigue does not establish that replacement therapy is appropriate. The Endocrine Society guideline describes the diagnostic framework.
The FDA continues to distinguish approved treatment for low testosterone associated with medical conditions from age-related use without an established indication. The 2025 labeling action retained the limitation concerning age-related hypogonadism. Our testing guide explains why repeat measurements and clinical interpretation come before a discussion of cardiovascular trial findings or formulation choice.
What TRAVERSE was designed to answer
TRAVERSE enrolled 5,246 men aged 45 to 80 with symptoms of hypogonadism, two fasting testosterone results below 300 ng/dL, and preexisting cardiovascular disease or high cardiovascular risk. Participants were assigned to daily 1.62% testosterone gel or placebo gel. The primary outcome combined cardiovascular death, nonfatal heart attack, and nonfatal stroke. The original trial report describes the design.
The study tested whether testosterone was not unacceptably worse than placebo for that specified outcome, using a prespecified noninferiority standard. It was not designed to prove that testosterone prevents heart disease or that every adverse event occurs at the same rate. The formulation and enrolled population are essential when applying the findings to another patient or product.
Understanding the main result
The primary cardiovascular outcome occurred in 7.0% of participants assigned to testosterone and 7.3% assigned to placebo. The trial met its noninferiority criterion. Average follow-up was about 33 months, and average treatment duration was about 22 months. These results provided important evidence for men similar to those enrolled.
The difference between 7.0% and 7.3% should not be presented as proof that testosterone protects the heart. The study’s statistical question was noninferiority, and its confidence interval allowed uncertainty around the relative effect. Nor does a reassuring result mean events did not occur. The practical interpretation is narrower: the specified major cardiovascular outcome was not shown to be unacceptably worse under the trial’s conditions.
Other findings and limitations still matter
TRAVERSE observed more atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group. These findings should be considered alongside the primary result rather than omitted from a general claim that TRT was proven safe. The trial also did not answer every question about lifelong treatment, all ages, all formulations, or exposure above therapeutic levels.
In particular, TRAVERSE used a transdermal gel. It was not a randomized comparison proving identical outcomes for testosterone cypionate injections. The trial report supports applying the findings with attention to population, route, and duration. Ask the clinician how closely the evidence matches your diagnosis, cardiovascular history, and proposed prescription.
What the FDA changed in February 2025
After reviewing TRAVERSE, the FDA announced removal of boxed-warning language about increased major adverse cardiovascular outcomes from testosterone labeling. It also required product information to reflect the trial results and retained the limitation concerning age-related hypogonadism. Separately, ambulatory blood-pressure studies led to new or expanded warnings about increased blood pressure. The FDA announcement describes these actions together.
This was a labeling update, not a declaration that all cardiovascular concerns disappeared. A product’s current prescribing information should guide its use. If an older article still describes the previous boxed language, check the date; if a newer article says all heart risks are gone, compare that claim with the actual FDA explanation.
Why blood pressure is a separate concern
Blood pressure reflects the force of blood against artery walls. A rise may occur without obvious symptoms, which is why feeling well cannot replace measurement. Persistent elevation can contribute to cardiovascular risk over time. Testosterone product labeling now emphasizes this issue based on dedicated blood-pressure evidence.
The current Depo-Testosterone label states that testosterone can increase blood pressure, recommends periodic monitoring, and does not recommend use in patients with uncontrolled hypertension. The label provides the product-specific language. Discuss existing hypertension, recent readings, and blood-pressure medicines before treatment. A reassuring result for one trial’s composite outcome does not make a new sustained pressure increase unimportant.
Make home monitoring useful if it is recommended
The American Heart Association recommends a validated automatic upper-arm monitor, an appropriate cuff size, and consistent measurement technique. Rest quietly, support the arm, and follow the recommended preparation steps. The clinician can advise how often to measure and which readings should prompt contact. The AHA’s home monitoring guide explains the process.
Bring a record of readings rather than selecting only the highest or lowest value. Include dates and relevant circumstances, such as illness or a medication change. Home monitoring can help assess a trend, but it does not replace clinical review. Do not independently alter testosterone or blood-pressure medicine in response to one result without following an agreed plan.
Baseline cardiovascular history changes the decision
Tell the prescriber about prior heart attack, stroke, heart failure, venous blood clots, irregular rhythms, kidney disease, diabetes, smoking, and blood-pressure control. Include the timing and current status of those conditions. The Endocrine Society recommends against starting testosterone after a heart attack or stroke within the previous six months and in uncontrolled heart failure, among other specified conditions.
These are reasons for individualized assessment, not a checklist to interpret alone. The guideline should be considered with current evidence and the treating clinician’s judgment. If cardiology or another specialist is involved, coordinate the plan so new symptoms and medication changes are visible to everyone responsible for care.
Hematocrit and blood pressure are different measurements
Testosterone can increase red blood cell production as well as affect blood pressure. Hematocrit measures the proportion of blood volume occupied by red cells; a blood-pressure cuff measures something else. A normal reading in one area does not establish that the other is acceptable.
The AUA recommends baseline and ongoing blood-count assessment and intervention for hematocrit of 54% or higher during therapy. The AUA guideline explains the management framework. Our hematocrit guide discusses why the underlying cause, dose exposure, sleep-related hypoxia, and other factors may need review. Repeated blood donation is not a substitute for assessing the overall treatment or controlling hypertension.
Symptoms can require urgent assessment
Chest pain, sudden shortness of breath, stroke-like symptoms, or a painful swollen leg need urgent medical attention. Do not wait for a routine testosterone appointment or try to resolve them with a dose change. Tell the treating team what product you use and when it was last administered.
Palpitations, persistent swelling, new exercise intolerance, or a sustained rise in home blood pressure also deserve timely discussion, with urgency determined by severity and associated symptoms. Ask the practice for clear contact instructions. A trial result cannot determine the cause of an individual symptom at home. Follow-up should make it easier to obtain assessment, not encourage self-reassurance that an event is impossible because treatment was prescribed.
Continue the rest of cardiovascular prevention
TRT does not replace smoking cessation, blood-pressure treatment, lipid management, diabetes care, physical activity, or assessment of sleep apnea. These measures address risks that may remain regardless of the testosterone level. The Endocrine Society also recommends against using testosterone simply to improve glycemic control in men with type 2 diabetes.
If the original complaint is fatigue or reduced exercise capacity, consider whether cardiovascular or sleep conditions may contribute. Improving a hormone measurement does not necessarily resolve those causes. The results guide explains why benefit should be tracked directly. A coordinated health plan keeps testosterone treatment in its proper role rather than turning it into a substitute for broader care.
Questions to ask when weighing the evidence
Ask which diagnosis supports TRT, how your cardiovascular history affects the choice, whether blood pressure is adequately controlled, and how monitoring will work. Discuss the formulation and how closely relevant trial evidence matches it. Clarify what would prompt a treatment change and which symptoms require urgent care.
Our first TRT consultation guide and monitoring article help organize these questions. The current evidence supports a more informed discussion than a simple claim that testosterone is either dangerous for every heart or proven risk-free. A useful decision keeps the trial’s findings, its limits, the product label, and your individual health circumstances in view.
Related reading
- Testosterone Replacement Therapy: Diagnosis, Benefits, and Treatment Options
- TRT and Hematocrit: Understanding Changes in Your Blood Count
- TRT, Muscle, and Body Composition: Hormone Levels Versus Physical Function
- Before Starting TRT: A Practical Guide to Evaluation and Treatment Planning
- Sermorelin and growth hormone: a different hormone pathway
- Creatine after 50 and strength training
Educational information. Individual treatment selection, prescription directions, and follow-up belong with the treating clinician. Linked guidance and source versions checked September 15, 2026. Medication instructions and evidence can differ by formulation and clinical use. Photographs are illustrative and do not show treatment outcomes.
