June is Men’s Health Month — and this year, providers have something genuinely new to talk about. On February 28, 2025, the FDA issued class-wide labeling changes for all testosterone products, removing the cardiovascular risk language from the boxed warning that had shaped a decade of prescribing hesitation. For clinicians who’ve watched men suffer with untreated hypogonadism out of fear of “heart risk,” the regulatory ground has shifted. The question now is whether clinical practice will catch up.
How We Got Here
In 2014 and 2015, the FDA added cardiovascular warnings to testosterone product labels based on observational studies that were later shown to be methodologically flawed. The result was predictable: providers backed away, men went undiagnosed and untreated, and an entire generation of clinicians was trained to view testosterone replacement therapy (TRT) as risky.
The numbers tell the story. An estimated 5.6% of men aged 30–79 have symptomatic testosterone deficiency, yet only 5–20% of those men receive treatment. The pattern echoes the post-WHI era for women: a piece of flawed evidence drove a generation of clinical caution, and patients paid the price.
What TRAVERSE Actually Showed
The FDA’s 2025 reversal was driven primarily by the TRAVERSE trial, published in the New England Journal of Medicine in July 2023. TRAVERSE was the largest randomized, placebo-controlled testosterone trial ever conducted: 5,246 hypogonadal men aged 45–80, all with preexisting or high cardiovascular risk, followed for a median of 33 months.
The findings were clear:
Testosterone replacement was noninferior to placebo for major adverse cardiac events
No increased risk of myocardial infarction, stroke, or cardiovascular death
No increased risk of prostate cancer or worsening lower urinary tract symptoms
The trial did note slightly higher rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group — clinically meaningful signals that warrant monitoring, not avoidance.
Based on these findings, the FDA removed the cardiovascular risk language from the boxed warning on all testosterone products. The agency also added a new warning about potential blood pressure elevation based on postmarket ambulatory blood pressure monitoring studies — a real consideration for provider follow-up, but a far cry from the prior message that TRT could kill your patient.
The Pattern Providers Should Recognize
This story should sound familiar. In November 2025, the FDA removed boxed warnings from low-dose vaginal estrogen products, finally aligning regulatory language with decades of evidence showing no increased risk of breast cancer, cardiovascular disease, or mortality. Now testosterone has followed the same trajectory.
Two hormones. Two decades of fear-driven prescribing. Two evidence-based reversals. The lesson for providers is the same: regulatory caution often lags clinical evidence by years, and patients suffer in the gap. The BHRT Training Academy has been teaching evidence-based hormone therapy ahead of these regulatory updates for years. The FDA is finally catching up.
What This Means for Clinical Practice
For providers seeing male patients in June and beyond, the practical implications are significant:
Screen routinely. Low testosterone is one of the strongest biomarkers of all-cause mortality in men — those in the highest testosterone quartile show roughly a 30% reduction in mortality compared to those in the lowest. A complete male hormone panel includes Total and Free Testosterone, SHBG, Estradiol, DHT, PSA, CBC, and LH (initially, to assess the underlying cause).
Don’t rely on Total T alone. SHBG and Free T are essential for accurate clinical interpretation. Optimal Total T is generally 600–1000 ng/dL, with Free T greater than 15 ng/dL.
Monitor what matters. Hematocrit, PSA, blood pressure, and estradiol should be tracked on a defined schedule for example — 3 weeks after injection initiation, 4–6 weeks after pellet insertion, 24 hours post topical application, with PSA annually (or at 6 months for new starts).
Address the metabolic loop. Low testosterone drives metabolic syndrome, and metabolic syndrome drives low testosterone. The T4DM trial showed that testosterone replacement combined with lifestyle intervention reduced new-onset type 2 diabetes by 40% in at-risk men. Treating one condition improves the other.
Know what hasn’t changed yet. The FDA’s “Limitation of Use” language — restricting TRT to men with hypogonadism from specific medical conditions rather than age-related decline alone — remains in place. Testosterone also remains a Schedule III controlled substance. Both are under active discussion in regulatory and professional circles, but neither has changed.
The Bottom Line
Men in the U.S. die roughly six years earlier than women, and low testosterone is implicated across many of the leading causes of that gap — cardiovascular disease, type 2 diabetes, depression, and frailty among them. The FDA’s February 2025 decision doesn’t make TRT a lifestyle drug or a longevity hack. It makes it what it always should have been: a legitimate, evidence-based therapy for a documented medical condition, no longer obscured by an outdated warning.
Men’s Health Month is the right moment to revisit who in your panel might benefit — and to act on what the evidence now clearly supports.
References
- U.S. Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. February 28, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. doi:10.1056/NEJMoa2215025
- Araujo AB, Esche GR, Kupelian V, et al. Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab. 2007;92(11):4241-4247. doi:10.1210/jc.2007-1245
- Shores MM, Matsumoto AM, Sloan KL, Kivlahan DR. Low serum testosterone and mortality in male veterans. Arch Intern Med. 2006;166(15):1660-1665. doi:10.1001/archinte.166.15.1660
- Wittert G, Bracken K, Robledo KP, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes Endocrinol. 2021;9(1):32-45. doi:10.1016/S2213-8587(20)30367-3
