HomeTopics › Testosterone Therapy

Testosterone Therapy

GMJ News knowledge hub · last reviewed August 2026 · Georgian Medical Journal

SummaryStatisticsGlossaryGMJ newsFAQDocumentsOrganizationsResearch

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 2013
5,246
men in the TRAVERSE cardiovascular safety trial — no excess major adverse cardiac events (HR 0.96)
Lincoff et al., NEJM 2023
2025
FDA revised testosterone class labelling after TRAVERSE — broad cardiovascular warning removed, blood-pressure information added
FDA drug safety communication, February 2025
morning testosterone measurements required for diagnosis under Endocrine Society guidelines — the standard, widely skipped
Endocrine Society clinical practice guideline
AF, AKI, PE
secondary signals in TRAVERSE — atrial fibrillation, acute kidney injury and pulmonary embolism — now noted in labelling
Lincoff et al., NEJM 2023

Where 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

Hypogonadism
clinical
Clinically low testosterone with symptoms, confirmed on at least two morning samples — the diagnosis that legitimately warrants replacement, as distinct from the marketing category of 'Low T'.
TRAVERSE
evidence
The 5,246-patient randomised cardiovascular safety trial (2023) mandated by the FDA, showing no excess major cardiac events and prompting the 2025 labelling revision — while flagging atrial fibrillation, kidney injury and pulmonary embolism signals.
Low T
marketing
The disease-branding campaign that converted normal male ageing into a treatable deficiency, tripling prescriptions in a decade — a canonical case study in condition marketing.
Morning measurement
clinical
Testosterone peaks in early morning and swings substantially during the day; diagnosis requires repeated morning sampling, which single afternoon telehealth tests structurally cannot provide.
Azoospermia
clinical
Absence of sperm — a predictable consequence of sustained exogenous testosterone suppressing the hypothalamic-pituitary-gonadal axis, and the mechanism of the fertility trap.
Haematocrit monitoring
clinical
Testosterone stimulates red-cell production; erythrocytosis is the most common laboratory adverse effect and the routine monitoring requirement most often skipped in subscription prescribing.

Latest GMJ coverage

Informal healthcare providers drive untracked antibiotic use across low- and middle-income countries
13/08/2026
Extra Virgin Olive Oil: 20 Grams Daily Linked to Lower Cancer and All-Cause Mortality
03/08/2026
Blood Type O Shows Lower Risk in Severe Malaria: Updated Meta-Analysis
31/07/2026
Daily Peanut Consumption Reverses a Decade of Age-Related Brain Blood Flow Decline
30/07/2026
Daily Peanut Consumption Linked to 4% Improvement in Brain Blood Flow in Older Adults
29/07/2026
Prenatal Iodine Deficiency Linked to Lower Verbal Intelligence in Adolescence, UK Study Finds
28/07/2026

Frequently asked questions 12 Q&A — structured for Google featured snippets and AI discovery

Knowledge hub: guidelines, conventions and reports

Organizations working in migration and health

Related health topics

Menopause Hormone TherapyInfertilityCardiovascular DiseaseProstate CancerObesitySupplements

About this hub. Produced by the GMJ News Editorial Team as a public-good service. Every statistic is linked to its primary source. Documents are preserved in the GMJ Repository with full attribution. Georgian Medical Journal · Contact the editorial team
GMJ BriefsView all →