Testosterone Therapy in 2026: What the FDA Panel, the TRAVERSE Trial, and Your Instagram Feed Aren’t Telling You

Testosterone replacement therapy has undergone a remarkable image makeover. A decade ago, TRT was associated with bodybuilders and baseball scandals. Today it’s pitched as a longevity protocol, a performance optimizer, a lifestyle upgrade. According to prescription data compiled by the healthcare analytics firm IQVIA, testosterone prescriptions in the U.S. climbed from roughly 7.3 million in 2019 to more than 11 million in 2024. Telehealth clinics have made it possible to get a prescription after a questionnaire and a single lab draw, sometimes without ever seeing a physician in person.

I should be straightforward about my position: I’m a family medicine physician who evaluates and manages hormone therapy, and this practice prescribes testosterone replacement therapy. I think TRT is genuinely underused in men who actually have hypogonadism. I also think the current cultural moment is creating a different problem entirely: healthy men with normal testosterone levels being sold a solution to a problem they don’t have. Read the rest knowing I profit from one half of that sentence and not the other.

Here’s what the evidence actually says — and what the podcasts, clinic ads and Instagram influencers are leaving out.

What actually counts as hypogonadism?

True hypogonadism is a clinical diagnosis, which means it takes both a number and a symptom. It requires persistently low testosterone levels — generally below 300 ng/dL on at least two morning fasting draws — alongside symptoms: fatigue, decreased libido, erectile dysfunction, loss of muscle mass, mood changes, or decreased bone density. The Endocrine Society’s clinical practice guidelines are explicit about this. A number alone doesn’t make a diagnosis, and symptoms alone don’t either. You need both.

This is where a lot of the current TRT marketing falls apart. A man whose testosterone comes back at 450 ng/dL — solidly normal — walks into a telehealth clinic feeling tired and stressed, gets told his levels are “suboptimal,” and walks out with a prescription. That isn’t treating hypogonadism. That’s treating a lab value that didn’t need treating.

Fact vs. Fad: The concept of “optimal” testosterone — as distinct from “normal” — is not an established medical standard. The reference range exists for a reason: it represents the range associated with normal physiological function across a large population. “Optimization” sounds scientific, but it’s a marketing term, not a clinical one. There is no evidence that pushing a man from 500 ng/dL to 900 ng/dL produces meaningful clinical benefit, and there is evidence that supraphysiologic levels carry risks.

What did the TRAVERSE trial actually show about safety?

For years, the biggest concern about TRT was cardiovascular risk. Small studies and retrospective analyses sent mixed signals, and in 2015 the FDA required manufacturers to conduct a proper safety trial. The result was TRAVERSE — a phase 4, randomized, double-blind, placebo-controlled trial enrolling 5,246 men aged 45 to 80 with confirmed hypogonadism and either preexisting cardiovascular disease or high risk of it, published in the New England Journal of Medicine in 2023.

The headline: testosterone therapy was noninferior to placebo for major adverse cardiovascular events. A major event occurred in 7.0% of men on testosterone and 7.3% on placebo. In plain English, it didn’t increase heart attacks, strokes or cardiovascular death. For men with genuine hypogonadism that is genuinely reassuring, and on the strength of it the FDA removed the cardiovascular boxed warning from testosterone products in February 2025.

But TRAVERSE also found something the headlines glossed over: higher rates of nonfatal arrhythmias, atrial fibrillation, pulmonary embolism and acute kidney injury in the testosterone group compared with placebo. The atrial fibrillation and kidney findings had not been reported in previous testosterone studies. They didn’t change the overall safety conclusion, but they are clinically relevant — particularly for men with preexisting heart rhythm issues or kidney concerns.

One detail worth holding onto: TRAVERSE used transdermal testosterone dosed to physiologic ranges, not the supraphysiologic levels that “optimization” clinics sometimes target. The trial tells you about replacement. It does not tell you about enhancement.

What did the December 2025 FDA panel actually recommend?

On 10 December 2025, the FDA convened a thirteen-member expert panel, drawn mainly from urology and federal health agencies, to review how testosterone therapy is regulated. The panel came out strongly in favor of wider access. Its recommendations included removing testosterone’s Schedule III controlled-substance classification, dropping prostate cancer warnings the panel considered unsupported by current evidence, and broadening the approved indication. The argument was that outdated fears about prostate cancer and cardiovascular disease have led to real undertreatment of men who genuinely need therapy.

I agree with that conclusion. But the panel’s discussion had a notable gap: very little attention was paid to the risks of overutilization — the growing population of men without true hypogonadism being prescribed testosterone for “optimization,” anti-aging or performance. Fertility implications and thromboembolic risk also received limited discussion.

The regulatory environment may be loosening. That makes physician judgment more important, not less.

Will testosterone therapy affect my fertility?

Yes, and this is the single biggest gap in the current TRT conversation — the one that concerns me most as a family medicine physician seeing younger men.

Exogenous testosterone suppresses the hypothalamic-pituitary-gonadal axis. Your brain detects high testosterone levels, stops sending luteinizing hormone and follicle-stimulating hormone to the testes, and sperm production drops — often to zero. This effect is well enough established that testosterone was studied for years as a male contraceptive.

Is it reversible? Usually. Most men regain baseline sperm counts within six to twelve months after stopping. But “most” is not “all.” Recovery can take up to two years, and men who have used testosterone for prolonged periods or at high doses may recover incompletely. Age and duration of use both predict a slower return of sperm counts.

Fact vs. Fad: I’ve seen men in their late twenties come in on TRT prescribed by a telehealth clinic, with no one having mentioned that the medication could make them infertile. No fertility counseling. No offer of sperm banking. No discussion of alternatives that can address symptoms while preserving sperm production. If you’re a man under 40 who might want biological children someday, this conversation needs to happen before you start — not when you’re trying to conceive and finding out your sperm count is zero.

Is more testosterone better?

No, and the evidence increasingly points the other way. There appears to be a therapeutic window — too low causes symptoms, too high may carry cardiovascular risk. The goal should be restoring physiologic levels in men who are genuinely deficient, not chasing the highest number the reference range will tolerate.

This is the point the optimization crowd tends not to engage with. Replacement and enhancement are different interventions with different evidence bases, and the safety data from replacement trials does not transfer to enhancement.

What’s wrong with telehealth testosterone clinics?

Telehealth is a legitimate and valuable tool in medicine. Testosterone telehealth as it currently operates has some serious problems.

A man fills out an online symptom questionnaire. He gets a single lab draw — sometimes not fasting, sometimes not in the morning, which matters because testosterone peaks in the early morning and can fall substantially by afternoon. If his number is below a threshold, which some clinics set higher than clinical guidelines suggest, he gets a prescription shipped to his door. No physical exam. No assessment of testicular size, which can distinguish primary from secondary hypogonadism. No fertility discussion. No screening for sleep apnea, which suppresses testosterone and is treatable without hormones. No evaluation for pituitary pathology, which requires an entirely different workup.

The Endocrine Society guidelines call for two confirmatory morning fasting testosterone levels before diagnosis, symptom assessment, and evaluation for reversible causes. A practice that skips those steps isn’t practicing efficient medicine. It’s practicing incomplete medicine.

What does a proper evaluation look like?

It starts with a history and an exam, not a lab slip. A comprehensive medical history including medication review, sleep assessment, stress and mood evaluation, and sexual health history. A physical exam including testicular assessment. Two confirmatory morning fasting testosterone levels drawn on separate days. If testosterone is low, we add LH, FSH, prolactin, thyroid function and a metabolic panel to work out the cause.

Before anyone writes a prescription, we go through the things that suppress testosterone and are fixable on their own — poor sleep, excess alcohol, chronic stress and excess weight, which is why weight and hormones keep turning up in the same conversation. If TRT is indicated after all that: fertility counseling, baseline hematocrit and PSA, and a monitoring protocol with regular lab work.

That isn’t being overly cautious. That’s being thorough, and it’s the difference between treating a symptom and treating a patient.

When is TRT the right call?

When a man has confirmed hypogonadism, has tried the lifestyle changes, and still has persistent symptoms alongside persistently low levels. I’ve seen it genuinely change quality of life for those men. The fatigue lifts. The mental fog clears. Libido returns. Muscle responds to exercise again. For the right patient, TRT is effective, well-studied and — on the strength of TRAVERSE — cardiovascularly safe when it’s monitored properly.

The issue isn’t TRT itself. It’s TRT prescribed without adequate evaluation, without fertility counseling, without monitoring, and to men who don’t meet the clinical criteria for treatment. The cultural shift toward testosterone as a wellness product is creating a population of men on lifelong hormone therapy who may never have needed it, and who weren’t told about the tradeoffs.

If you think your testosterone might be low, start with a physician who will do the full workup rather than a clinic that will do the minimum to justify a prescription. A complimentary consultation will tell you whether testing is warranted and, if your levels are genuinely low, what your options actually are.

References

Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. New England Journal of Medicine. 2023;389(2):107–117. doi:10.1056/NEJMoa2215025

Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology and Metabolism. 2018;103(5):1715–1744. doi:10.1210/jc.2018-00229

U.S. Food and Drug Administration. Expert panel on testosterone replacement therapy for men; 10 December 2025. Docket FDA-2025-N-6743. (advisory panel proceedings)

U.S. Food and Drug Administration. Removal of the cardiovascular boxed warning from testosterone products; February 2025. (labeling change)

IQVIA. U.S. testosterone prescription volumes, 2019–2024. (commercial prescription database)