New clinical evidence supports broader access. But the bigger story is a fundamental misunderstanding about who should actually be treated.
The FDA is considering loosening how testosterone therapy is prescribed. The Department of Health and Human Services has proposed removing some long-standing restrictions: the blanket rules against treating age-related low testosterone, the blanket contraindication for men with a history of prostate cancer, and the overly broad warnings about benign prostate problems. On the surface, this is good news for men who have symptoms and genuinely low levels but have been refused treatment or had to fight for it. But the proposal also reveals something deeper: most people don't understand how testosterone diagnosis should actually work.
For years, testosterone therapy carried a reputation of cardiovascular risk. Older studies, some flawed and some misinterpreted, suggested that giving men testosterone increased heart attacks and strokes. Prescribing it became cautious or rare, even for men with clear symptoms and confirmed low levels.
Then came the TRAVERSE trial. Published in 2023, this was a large, well-designed study that enrolled over 5,200 men aged 45 to 80 with symptoms of low testosterone and documented cardiovascular risk factors. These weren't young, healthy men—they were the highest-risk population. Over 33 months, researchers compared men on testosterone therapy to those on placebo and carefully tracked major cardiac events like heart attacks and strokes. The result: no significant difference. Testosterone therapy in this population did not increase cardiovascular risk.
That's a meaningful finding. It closed a chapter on an old fear and opened the door to reconsidering who should be treated. Some experts, citing this evidence, now argue that the old restrictions are outdated and prevent men from accessing therapy they could genuinely benefit from.
But here's what nobody's talking about loudly enough: most men taking testosterone right now in the United States don't actually have low testosterone. They have symptoms—fatigue, low mood, sexual difficulty—but their lab work is normal or borderline. And they're on testosterone therapy anyway, prescribed based on symptoms alone.
This is exactly backward. The new TRAVERSE data supports treating men whose blood tests show genuinely low testosterone. It does not support treating men whose labs are normal, no matter what they feel like.
Here's the critical nuance: a testosterone level that falls into the "normal" range on a lab test should not be treated with testosterone, period. Not because the man doesn't have symptoms, but because giving him testosterone when his body is already producing a normal amount doesn't make medical sense and carries unnecessary risks. He's not deficient. He doesn't have the condition.
At the other end of the spectrum, there's an equally real problem: men with confirmed low levels and real symptoms are being told "sorry, you're too old" or "sorry, you had prostate cancer once" or "sorry, you have enlarged prostate." These blanket rejections don't make sense either. An older man with documented low testosterone and symptoms that affect his quality of life, given that the TRAVERSE data shows no cardiac danger, deserves individualized evaluation and a chance at treatment.
The FDA's proposed label changes are frankly acknowledging something that's been true for years: rigid, population-level rules fail individual patients. But the unspoken flip side is also true: anyone can invoke "personalized medicine" as license to treat symptoms without checking labs, and that's harmful too.
That's the real conversation that needs to happen. Not "testosterone is safe, so more men should get it" but "here's how to diagnose low testosterone correctly so that men who actually have it can access treatment, and men who don't have it won't be unnecessarily exposed."
A reasonable standard looks like this: Testosterone therapy is appropriate for men who have both symptoms of hypogonadism and confirmed low testosterone on blood work. That confirmation should be done carefully—multiple measurements if there's any ambiguity, testing at the right time of day, knowing what "low" actually means for that individual in context of his symptoms and trajectory. Population cutoffs like "below 300 ng/dL" are statistical thresholds, not gospel. One man's correct starting point might be 350, while another's might be 280. That's where individualized medicine comes in.
But "he has fatigue and his mom's cousin felt better on testosterone" is not diagnosis. And "his testosterone is 450 ng/dL but he wants to feel more energetic" is not deficiency, even if the patient is persuasive or the prescriber is careless.
The TRAVERSE trial, for all its rigor, tested one product (AndroGel testosterone gel) in men ages 45 to 80 with documented low testosterone and symptoms over roughly 33 months. The study did not show that testosterone is universally safe for all uses. It did not show that men without low testosterone should be treated. It showed that treating the right population—men with confirmed low levels—has a better safety profile than fear suggested.
The trial had limitations worth knowing. Sixty-one percent of men dropped out before the end, limiting what we can say about very long-term safety. Men at extremely high prostate cancer risk were excluded, so we don't have data on them. And while the data are reassuring, 33 months is still a relatively short follow-up for long-term therapy.
What the evidence does support is this: if a man has symptoms consistent with low testosterone, has had his testosterone level checked and confirmed to be genuinely low, and has realistic expectations about what testosterone therapy can and cannot do, there's good reason to consider treatment and no major cardiac red flag.
A competent testosterone evaluation includes:
This is exactly how testosterone therapy works at Empower Med. Every patient starts with a consultation and lab work. We measure testosterone, but we also measure your other hormones, metabolic markers, and baseline sexual function so we know what's actually happening and what else might be playing a role. Then Dr. Everson works with you on dosing, expectation-setting, and whether testosterone is genuinely the right tool for your situation. The membership model—not a one-off prescription—means ongoing monitoring, annual labs, and the chance to adjust if something isn't working or if your situation changes.
This kind of care takes time and attention. It's the opposite of symptom-based prescribing or population-based guessing. It's why the diagnosis matters as much as the treatment.
If you're experiencing fatigue, low mood, sexual difficulty, or reduced energy, the first step isn't assuming testosterone is the answer. It's getting competent evaluation: accurate measurements, not just a symptom checklist. If your testosterone really is low, there's now good evidence that treating it is worth exploring. If it's normal, then something else is driving your symptoms—maybe sleep, stress, diet, another hormone, or a medical condition that deserves its own diagnosis.
The FDA's willingness to reconsider old restrictions is overdue. Men with genuine hypogonadism have been under-served by outdated blanket rules. But better access should never mean lower standards. It should mean more men who actually need and can benefit from treatment get it, and fewer men unnecessarily exposed to therapy they don't need.
That distinction is everything. And it starts with diagnosis that takes your individual situation seriously, not just your symptoms.
The first step is accurate diagnosis. Empower Med's approach to Male Hormone Optimization begins with thorough lab work, a detailed clinical evaluation, and realistic expectations about what testosterone therapy can do for your specific situation. Dr. Everson can help determine whether low testosterone is actually the issue and, if it is, whether treatment is right for you.
A consultation clarifies what's driving your symptoms and whether testosterone therapy—or something else entirely—is the best path forward.
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