How the Industry Grew

Testosterone prescribing in the US grew from approximately 0.8 million prescriptions in 2001 to over 7.5 million by 2016, a roughly tenfold increase in fifteen years.[1] This expansion was not driven primarily by a growing population of men with documented hypogonadism. It was driven by the marketing of low testosterone as an explanation for the normal symptoms of aging — fatigue, reduced libido, weight gain, diminished vitality — and the creation of a direct-to-consumer pipeline that made obtaining testosterone fast, easy, and medically uncritical.

Low-T clinics and DTC testosterone services typically operate outside the diagnostic framework that guidelines require. Many do not insist on two fasting, early-morning testosterone measurements before prescribing. Many do not require symptoms that are specific to hypogonadism. Many do not investigate why testosterone is low before treating the number. And many do not provide ongoing monitoring that would catch erythrocytosis or other adverse effects before they become serious problems.

📊 The Evidence — Who Is Actually Being Treated

Much of the increase in testosterone use over the past two decades has been in men with nonspecific symptoms like decreased energy who have low or low-normal testosterone attributable to obesity, poor sleep, or other comorbidities rather than primary hypogonadism.[2] The American College of Physicians explicitly recommends against initiating testosterone therapy to improve energy, vitality, physical function, or cognition in men with age-related low testosterone — citing very little or no benefit for these outcomes.[3]

A comprehensive review concluded that neither the clinical consequences of low testosterone in aging men nor the magnitude of treatment benefits justify broadly applied testosterone replacement in older men with low levels.[4] This is not a fringe position — it is the consensus of the major endocrinology and urology guidelines.

The Cardiovascular Question — and What TRAVERSE Actually Showed

For years, the cardiovascular safety of testosterone therapy was genuinely uncertain. Small trials gave conflicting results. Observational studies pointed in different directions. In 2015, the FDA required testosterone manufacturers to fund a large, rigorous trial to settle the question. That trial was TRAVERSE.

📊 The Evidence — The TRAVERSE Trial

TRAVERSE enrolled 5,246 men aged 45–80 with documented hypogonadism — confirmed by two fasting early-morning testosterone levels below 300 ng/dL — and either established cardiovascular disease or high cardiovascular risk. They were randomized to daily transdermal testosterone gel or placebo for an average of 27 months, with doses adjusted to keep testosterone in the 400–750 ng/dL range.[5]

The primary result: testosterone was noninferior to placebo for major adverse cardiovascular events — heart attack, stroke, and cardiovascular death occurred in 7.0% of the testosterone group vs. 7.3% of the placebo group, a difference that was not statistically significant.[5] This is genuinely reassuring news for men with confirmed hypogonadism who need treatment.

But TRAVERSE also found signals that deserve attention. Atrial fibrillation requiring intervention occurred in 5.2% of testosterone-treated men vs. 3.3% of placebo — a meaningful difference.[5] Venous thromboembolic events (blood clots) were also more common in the testosterone group. And fractures were higher, though the mechanism is not fully understood. The trial chair, Dr. Steven Nissen of the Cleveland Clinic, stated plainly: this study should not be used as justification for widespread testosterone prescribing to aging men who don't meet the diagnostic criteria.[6]

⚠ Who TRAVERSE Does and Doesn't Apply To TRAVERSE studied men with documented hypogonadism — two confirmed low morning testosterone measurements, plus symptoms — who were carefully monitored with dose adjustments throughout. Its reassuring cardiovascular findings apply to that population. They do not apply to:
  • Men with low-normal testosterone and nonspecific symptoms like fatigue
  • Men who received a single afternoon testosterone measurement
  • Men prescribed testosterone without ongoing lab monitoring
  • Men taking supraphysiologic doses through DTC services
  • Men whose low testosterone is due to obesity or other reversible causes
Using TRAVERSE to reassure patients that testosterone is "proven safe" for anyone who wants it misrepresents what the study found.

The Scale of the Problem

10×
increase in testosterone prescriptions in the US between 2001 and 2016 [1]
5.2%
vs. 3.3% rate of atrial fibrillation requiring intervention — testosterone vs. placebo in TRAVERSE [5]
~0
benefit found for energy, vitality, or cognition in men with age-related low testosterone per ACP review [3]

What DTC Testosterone Services Often Get Wrong

The DTC testosterone model has grown substantially, and some providers operating within it do follow appropriate diagnostic and monitoring standards. But the model creates structural pressures that work against good practice — subscription revenue depends on continued prescribing, telemedicine makes it easy to skip a physical exam, and the marketing promise of restored vitality creates patient expectations that drive toward prescribing regardless of whether the diagnosis is sound.

The specific problems I see most often when patients come to me after starting testosterone through a DTC service are: a single low-normal testosterone level used as the basis for prescribing, no inquiry into why testosterone was low, no baseline hematocrit before starting, no follow-up labs after starting, and doses that push testosterone well above the upper end of the normal range. These aren't minor protocol variations — they're the specific gaps that let serious adverse effects develop undetected.

My Synthesis I'm careful not to assume bad faith on the part of providers working in this space. Some genuinely believe in what they're doing, and the evidence on testosterone's benefits for confirmed hypogonadism is real enough that the enthusiasm is understandable. What I push back on is the diagnostic standards — or the absence of them. A patient who comes to me after two years on testosterone from a DTC clinic, feels no different than before, has a hematocrit of 52%, and was never tested for sleep apnea is not a patient who was helped by that treatment. He was put at risk for a problem he didn't have. That's the version of this story I see regularly, and it's why the diagnostic bar matters.

If You're Considering Testosterone Therapy

If you're thinking about testosterone therapy — whether through a primary care provider, an endocrinologist, or a DTC service — here are the questions worth asking before starting. A provider doing this properly should be able to answer all of them.

Questions to ask before starting testosterone

  • Were my testosterone levels measured on at least two separate mornings, while fasting?
  • Is my testosterone level genuinely below 300 ng/dL — not just low-normal?
  • Do I have specific symptoms of hypogonadism — particularly changes in sexual function — not just fatigue?
  • Has anyone looked into why my testosterone is low before prescribing?
  • Has my hematocrit been checked before starting?
  • Will my levels be monitored after starting, and how often?
  • Have we discussed what happens to my fertility on testosterone?
  • What is the plan if my hematocrit rises too high?
  • What are the realistic expectations for what testosterone will and won't improve?

If a provider can't or won't answer these questions, that's important information. Testosterone therapy for genuine hypogonadism is effective and, when properly monitored, safe. The goal of this checklist isn't to discourage treatment — it's to help patients distinguish between a provider practicing evidence-based medicine and one operating from a different set of priorities.

My Synthesis The Low-T industry has done real harm — not just to individual patients who've been overtreated, but to the broader credibility of testosterone therapy as a legitimate medical intervention. When I prescribe testosterone, I'm doing it within a diagnostic framework that the major guidelines support, with monitoring in place, and with realistic expectations set upfront. The evidence for testosterone in true hypogonadism is good. The evidence for testosterone as a general vitality treatment for aging men is not. Keeping those two things clearly separate is the job — and it's a job the Low-T industry has repeatedly chosen not to do.