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Testosterone Therapy
GMJ News knowledge hub · last reviewed August 2026 · Georgian Medical Journal
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Testosterone prescribing tripled in a decade on the back of “Low T” marketing aimed at healthy ageing men, then contracted under a cardiovascular warning that the 5,246-patient TRAVERSE trial largely dismantled in 2023, showing no excess in major cardiac events and prompting US regulators to rewrite the class labelling in 2025. The trial settled the question it asked — cardiovascular safety in men with genuine hypogonadism — while leaving the larger commercial phenomenon untouched: a substantial share of prescriptions are still written without confirmatory morning testosterone measurements, increasingly through direct-to-consumer telehealth platforms. Evidence, marketing and the fertility trap are separated below (see the WHO infertility fact sheet).
Key messages
SETTLED: real hypogonadism benefits from treatment
Men with confirmed hypogonadism — consistently low morning testosterone plus symptoms, often from testicular or pituitary disease — benefit from replacement: improved sexual function, bone density, anaemia correction and modest mood and energy gains, as the NIH-funded TTrials documented in older men with unequivocally low levels. None of the controversy touches this population; the entire debate concerns the vastly larger group of ageing men with borderline levels and nonspecific symptoms to whom the diagnosis was marketed. Endocrine Society guidance is clear that diagnosis requires at least two morning measurements — a standard a striking share of real-world prescribing has never met.
THE MARKETING PHENOMENON: manufacturing Low T
'Low T' was one of the most effective disease-branding campaigns in pharmaceutical history: US testosterone prescribing roughly tripled between 2001 and 2011, driven by direct-to-consumer advertising that converted normal ageing — lower energy, reduced libido, more body fat — into a treatable deficiency. Studies through the boom years found that roughly a quarter of men starting therapy had no recorded testosterone measurement at all, and many more had levels in the normal range. The pattern has now migrated online: direct-to-consumer telehealth platforms prescribe after questionnaires and single afternoon tests, reproducing the 2000s playbook with a subscription model.
TRAVERSE 2023: the cardiovascular question answered — for its population
The 2015 FDA cardiovascular warning rested on weak observational signals, and the agency demanded a proper trial. TRAVERSE delivered it: 5,246 middle-aged and older men with hypogonadism and elevated cardiovascular risk, randomised to testosterone gel or placebo — no excess in major adverse cardiac events (hazard ratio 0.96). On that basis the FDA revised class labelling in early 2025, removing the broad cardiovascular warning while adding notes on blood-pressure effects and the secondary signals the trial did observe: more atrial fibrillation, acute kidney injury and pulmonary embolism. TRAVERSE answers the question for diagnosed hypogonadal men; it says nothing about enhancement use in men with normal levels.
GENUINELY OPEN: the grey zone and the long term
What remains unsettled is the population marketing created: ageing men with low-normal levels and nonspecific symptoms. Whether they benefit meaningfully, whether years of supraphysiologic dosing through some clinics is safe, and what happens to prostate outcomes over decades of modern prescribing are open questions — TRAVERSE ran under five years in a screened population. The old belief that testosterone causes prostate cancer has softened considerably, but long-horizon surveillance in real-world users, particularly those using doses aimed at gym performance rather than replacement, simply does not exist.
THE FERTILITY TRAP
The least-communicated fact in the field: exogenous testosterone suppresses the hormonal axis that drives sperm production, and sustained use can render men azoospermic — sometimes irreversibly after long exposure. Surveys of urologists report steady traffic of young men whose infertility workup reveals prescription testosterone as the cause, frequently started by clinics that never mentioned it. For men who may want children, alternatives that preserve spermatogenesis (clomiphene, hCG) exist, and their omission from a prescribing conversation is a consent failure, not a detail.
PRACTICAL BOTTOM LINE
Two properly done morning tests before any diagnosis; treat confirmed hypogonadism, ideally through a clinician who will also monitor haematocrit, blood pressure and prostate parameters; and treat TRAVERSE as reassurance for that population rather than a licence for enhancement use. Men considering therapy who may want children need the fertility conversation first. And a testosterone prescription issued after an online questionnaire, without confirmatory testing or fertility counselling, is a commercial transaction wearing clinical dress — the same product the 2000s sold on television, now sold by subscription.
Key statistics
~3×
increase in US testosterone prescribing between 2001 and 2011 during the Low T marketing era
Baillargeon et al., JAMA Internal Medicine 2013~25%
of men starting therapy in the boom years had no recorded testosterone measurement before prescription
Baillargeon et al., JAMA Internal Medicine 20135,246
men in the TRAVERSE cardiovascular safety trial — no excess major adverse cardiac events (HR 0.96)
Lincoff et al., NEJM 20232025
FDA revised testosterone class labelling after TRAVERSE — broad cardiovascular warning removed, blood-pressure information added
FDA drug safety communication, February 20252×
morning testosterone measurements required for diagnosis under Endocrine Society guidelines — the standard, widely skipped
Endocrine Society clinical practice guidelineAF, AKI, PE
secondary signals in TRAVERSE — atrial fibrillation, acute kidney injury and pulmonary embolism — now noted in labelling
Lincoff et al., NEJM 2023Where the disagreement actually lies
Each claim scored by strength of evidence — not by popularity.
Benefit in confirmed hypogonadism (settled)90
MACE safety in treated hypogonadism (TRAVERSE, strong)80
Fertility suppression from exogenous T (settled)90
Benefit in low-normal ageing men (open)40
Long-term safety of enhancement dosing (unknown)25
Testosterone as general anti-ageing therapy (unsupported)10
■ settled / strong ■ genuinely open / contested ■ weak / unsupported / refuted
Source: Editorial synthesis of TRAVERSE, TTrials and prescribing studies
Glossary of key terms
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