The TRAVERSE Trial and the New Era of Hormone Therapy

For years, testosterone therapy carried a cloud of controversy. Many clinicians hesitated to prescribe it, haunted by headlines linking hormones to heart attacks, strokes, and prostate cancer. Those fears came from older, inconsistent data, mostly from small or flawed studies that did not reflect real-world patients.

Then came the TRAVERSE Trial, published in The New England Journal of Medicine in 2023. It is the largest and most rigorous testosterone study ever conducted, with over 5,000 men who had both documented low testosterone and either existing or high-risk cardiovascular disease. Participants were randomized to daily testosterone gel or placebo and followed for about three years.

The results changed the conversation.

What TRAVERSE Found

Men on testosterone therapy did NOT have a higher risk of heart attack, stroke, or death from cardiovascular causes than men on placebo. In numbers: 7.0% vs 7.3%. Statistically identical.

Rates of prostate cancer and other serious adverse events were also similar. The only differences seen were small increases in atrial fibrillation, pulmonary embolism, and acute kidney injury, which are signals worth monitoring but far less concerning than past assumptions.

In plain language, for men appropriately diagnosed with low testosterone and treated under medical supervision, testosterone therapy was NOT shown to raise major cardiovascular risk.

That is a landmark finding.

Why It Matters

TRAVERSE did not prove that testosterone therapy is a fountain of youth. But it refuted the idea that TRT is inherently dangerous, especially when used in the right patients.

It gives clinicians confidence to revisit treatment for men who have been told for years to "just live with it." Fatigue, low libido, muscle loss, poor concentration—symptoms often dismissed as "normal aging"—now deserve a second look supported by stronger evidence.

The study also sets a new research standard. It used clear diagnostic criteria, proper dosing, and modern formulations. It separated real hypogonadism from over-the-counter hormone fads and unregulated clinics that blurred the field.

Why You May Not Hear About It Soon

Traditional medicine moves slowly. Guidelines must be reviewed, committees must meet, and insurers must update coverage policies. That process takes years.

While forward-thinking clinicians are already integrating TRAVERSE findings into their care, many primary care offices and insurance-driven clinics will still operate under older caution.

This is not bad intent, but institutional inertia. Medicine is designed to change carefully, not quickly. Unfortunately, that means patients often wait years for care that is already supported by data.

The Takeaway

The TRAVERSE Trial did not just clear testosterone’s name. It clarified the rules for safe, evidence-based hormone therapy. It showed that when HRT is done right, it can be both effective and safe for the right population.

For patients and providers alike, it is a reminder that science evolves—and good medicine should evolve with it.

https://www.nejm.org/doi/full/10.1056/NEJMoa2215025