Testosterone Therapy and Heart Health: What the TRAVERSE Trial Means for Men

For years, one of the biggest concerns surrounding testosterone replacement therapy (TRT) has been its potential impact on cardiovascular health.

Patients frequently ask:

• Does testosterone increase the risk of heart attacks?

• Can TRT cause strokes?

• Is testosterone dangerous for men with heart disease?

• Why do some testosterone products carry cardiovascular warnings?

These concerns largely stem from studies published more than a decade ago that suggested testosterone therapy might increase cardiovascular risk. Those studies received significant media attention and ultimately led the U.S. Food and Drug Administration (FDA) to require a large-scale safety trial to better answer the question.

Today, we finally have that answer.

The results of the landmark TRAVERSE Trial have significantly changed our understanding of testosterone therapy and cardiovascular health, leading the FDA to remove longstanding cardiovascular risk warnings from testosterone product labeling in 2025.

Why Was There Concern About Testosterone and Heart Disease?

The controversy began in the early 2010s when several observational studies suggested testosterone therapy might increase the risk of heart attacks, strokes, and cardiovascular-related death.

These studies generated widespread concern among physicians, patients, and regulators. As a result, the FDA required manufacturers to conduct a large, prospective cardiovascular outcomes trial specifically designed to evaluate the long-term safety of testosterone therapy.

That study became known as TRAVERSE.

What Is the TRAVERSE Trial?

The TRAVERSE Trial (Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men) was the largest and most rigorous testosterone cardiovascular safety study ever conducted.

The study enrolled more than 5,200 men between the ages of 45 and 80 who:

• Had symptoms of testosterone deficiency

• Had documented low testosterone levels

• Had existing cardiovascular disease or elevated cardiovascular risk

Participants were randomly assigned to receive either testosterone therapy or placebo and were followed for approximately 33 months.

The primary goal was straightforward:

Would testosterone therapy increase the risk of major cardiovascular events such as heart attack, stroke, or cardiovascular death?

What Did the Study Find?

The results were clear.

Men receiving testosterone therapy experienced cardiovascular event rates that were nearly identical to those receiving placebo. The primary cardiovascular endpoint occurred in 7.0% of men receiving testosterone compared to 7.3% of men receiving placebo.

In other words, testosterone therapy did not increase the risk of major adverse cardiovascular events.

The investigators concluded that testosterone therapy was non-inferior to placebo with respect to cardiovascular safety in appropriately selected men with documented hypogonadism.

This finding was particularly important because the study specifically included men who already had elevated cardiovascular risk.

The FDA Responds

The TRAVERSE Trial was conducted largely because of FDA concerns regarding cardiovascular safety.

After reviewing the data, the FDA announced class-wide labeling changes for testosterone products in February 2025. The agency stated that the TRAVERSE Trial demonstrated no increase in major adverse cardiovascular outcomes among men receiving testosterone therapy for hypogonadism.

As a result, the FDA removed the boxed warning language that previously suggested an increased risk of cardiovascular events from testosterone product labels. The FDA also directed manufacturers to include information from the TRAVERSE Trial in product labeling.

This represents one of the most significant regulatory shifts in men's health over the past decade.

Does This Mean Testosterone Is Risk-Free?

Not exactly.

Like any medical treatment, testosterone therapy still requires proper evaluation, monitoring, and individualized care.

The TRAVERSE Trial demonstrated that testosterone therapy did not increase the risk of heart attack, stroke, or cardiovascular death when used appropriately in men with confirmed testosterone deficiency.

However, the study also identified certain findings that continue to warrant attention, including higher rates of atrial fibrillation, pulmonary embolism, and acute kidney injury in some patients. These findings reinforce the importance of medical supervision and ongoing monitoring.

Additionally, the FDA now requires warnings regarding potential increases in blood pressure associated with testosterone therapy.

This means testosterone therapy should never be approached as a "one-size-fits-all" treatment.

What This Means for Men Considering TRT

Perhaps the most important takeaway from the TRAVERSE Trial is that many of the longstanding fears surrounding testosterone therapy and cardiovascular disease have not been supported by the highest-quality evidence available.

For men with documented testosterone deficiency and appropriate symptoms, the discussion has shifted from:

"Does testosterone cause heart attacks?"

to

"Is testosterone therapy appropriate for this patient?"

That is a much different conversation.

Modern hormone optimization focuses on:

• Confirming true testosterone deficiency

• Identifying underlying causes

• Evaluating cardiovascular risk factors

• Monitoring blood counts and hormone levels

• Optimizing dosing

• Following patients over time

When performed appropriately, testosterone therapy can help improve:

• Energy

• Libido

• Sexual function

• Body composition

• Mood

• Muscle mass

• Quality of life

while maintaining an acceptable cardiovascular safety profile.

The Bigger Picture: Low Testosterone May Be a Cardiovascular Risk Factor

An interesting aspect of the testosterone discussion is that low testosterone itself has been associated with numerous adverse health outcomes.

Research has linked testosterone deficiency to:

• Increased body fat

• Insulin resistance

• Type 2 diabetes

• Metabolic syndrome

• Reduced muscle mass

• Increased cardiovascular risk

While testosterone therapy is not a substitute for healthy lifestyle habits, treating clinically significant testosterone deficiency may be an important component of improving overall health in appropriate patients.

The Bottom Line

The TRAVERSE Trial represents one of the most important developments in men's health in recent years.

After following more than 5,000 men with low testosterone and elevated cardiovascular risk, researchers found that testosterone therapy did not increase the risk of heart attack, stroke, or cardiovascular death when compared to placebo.

In response to these findings, the FDA removed longstanding cardiovascular risk language from testosterone product labels and now requires inclusion of TRAVERSE data in testosterone prescribing information.

The message is not that testosterone therapy is appropriate for every man. Rather, it is that testosterone therapy can be used safely in appropriately selected and monitored patients with documented testosterone deficiency.

At Hydro Med Spa, we believe every patient deserves an individualized evaluation that looks beyond a single laboratory value. Through comprehensive testing, careful monitoring, and personalized treatment plans, we help men make informed decisions about their health while prioritizing both safety and long-term outcomes.

If you're experiencing symptoms of low testosterone and would like to learn whether TRT may be appropriate for you, schedule a consultation with our team today.