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© 2026 variis · Singapore · Australia

  1. Home
  2. Protocols
  3. Testosterone replacement therapy (TRT)

Protocol

Testosterone replacement therapy (TRT)

TRT · androgen replacement · androgen replacement therapy · andropause treatment · male hormone therapy · testosterone therapy · testosterone optimisation

TRT has genuine randomised human evidence, which puts it well ahead of most longevity clinic offerings, but the evidence supports narrower claims than the marketing does. TRAVERSE (n=5,246 men aged 45 to 80 with hypogonadal symptoms, testosterone under 300 ng/dL, and existing or high cardiovascular risk; NEJM 2023) found daily 1.62% testosterone gel non-inferior to placebo for major adverse cardiac events (7.0% vs 7.3%; HR 0.96, 95% CI 0.78 to 1.17). That is a safety result, not a benefit result: TRAVERSE showed TRT does not appear to raise MACE risk in that population, while also recording small excesses of atrial fibrillation, pulmonary embolism and fracture. The Australian T4DM trial (Wittert et al., Lancet Diabetes & Endocrinology 2021; n=1,007 men aged 50 to 74 with impaired glucose tolerance or new type 2 diabetes and testosterone at or below 14.0 nmol/L, explicitly WITHOUT pathological hypogonadism) found that two years of testosterone undecanoate added to a lifestyle programme cut two-year type 2 diabetes incidence by roughly 40%, with fat loss and strength gains. Notably, T4DM's own lead investigator cautioned that testosterone is not a substitute for lifestyle intervention, and follow-up reporting indicates the diabetes-prevention effect was not durable once treatment stopped. What the evidence does NOT show: no trial has demonstrated that TRT extends lifespan, reduces all-cause mortality, slows biological ageing, or improves any validated healthspan endpoint. There is no RCT evidence supporting testosterone in men with normal testosterone levels, and the long-term effects of decades-long supraphysiological or "optimisation" dosing outside diagnosed deficiency are untested. Fertility suppression is a real and sometimes irreversible consequence. The honest grade is: strong clinical evidence for symptom and metabolic outcomes in confirmed deficiency, no evidence for the longevity claim itself.

At a glance

Evidence
Clinical
Singapore (HSA)
Registered and prescription-only. Testosterone products are registered therapeutic products with HSA and classified as Prescription Only Medicines. Nebido (testosterone undecanoate 1,000 mg/4 mL) holds Singapore registration number SIN13281P, listed on the MOH National Drug Formulary as a Prescription Only Medicine, indicated for testosterone replacement therapy in adult males with testosterone deficiency confirmed by clinical features and biochemical testing. Other registered options in Singapore include testosterone gel and testosterone ester injections. Prescribing requires a licensed medical practitioner and biochemically confirmed deficiency; there is no HSA-approved indication for testosterone as an anti-ageing, performance or longevity-optimisation intervention, so use in men without confirmed deficiency is off-label.
Australia (TGA)
Registered on the ARTG and Schedule 4 (prescription-only). Testosterone undecanoate 1,000 mg/4 mL is ARTG-registered as Reandron 1000 (ARTG 106946 ampoule, 213942 vial; sponsor Aspen Pharmacare Australia), with several later generics (Rejunon, Gonadron, Reanmed, Testosterone SUN); transdermal testosterone products are also registered. The TGA-approved indication is testosterone replacement therapy for confirmed testosterone deficiency / male hypogonadism established by clinical features and biochemical tests. PBS subsidy is Authority Required and tightly restricted: androgen deficiency with an established pituitary or testicular disorder, or, for men 40 and over without such a disorder, androgen deficiency confirmed on at least two separate morning blood samples (testosterone below 8 nmol/L, or 8 to 15 nmol/L with elevated LH). Testosterone is neither TGA-approved nor PBS-subsidised for age-related testosterone decline, "andropause", anti-ageing or performance optimisation; prescribing for those purposes is off-label and private-pay.
Offered at
2 clinics

Singapore

Health Sciences Authority

HSA status
Registered and prescription-only. Testosterone products are registered therapeutic products with HSA and classified as Prescription Only Medicines. Nebido (testosterone undecanoate 1,000 mg/4 mL) holds Singapore registration number SIN13281P, listed on the MOH National Drug Formulary as a Prescription Only Medicine, indicated for testosterone replacement therapy in adult males with testosterone deficiency confirmed by clinical features and biochemical testing. Other registered options in Singapore include testosterone gel and testosterone ester injections. Prescribing requires a licensed medical practitioner and biochemically confirmed deficiency; there is no HSA-approved indication for testosterone as an anti-ageing, performance or longevity-optimisation intervention, so use in men without confirmed deficiency is off-label.
In our SG set
Tracked in Singapore
SG clinics
1

Australia

Therapeutic Goods Administration

TGA status
Registered on the ARTG and Schedule 4 (prescription-only). Testosterone undecanoate 1,000 mg/4 mL is ARTG-registered as Reandron 1000 (ARTG 106946 ampoule, 213942 vial; sponsor Aspen Pharmacare Australia), with several later generics (Rejunon, Gonadron, Reanmed, Testosterone SUN); transdermal testosterone products are also registered. The TGA-approved indication is testosterone replacement therapy for confirmed testosterone deficiency / male hypogonadism established by clinical features and biochemical tests. PBS subsidy is Authority Required and tightly restricted: androgen deficiency with an established pituitary or testicular disorder, or, for men 40 and over without such a disorder, androgen deficiency confirmed on at least two separate morning blood samples (testosterone below 8 nmol/L, or 8 to 15 nmol/L with elevated LH). Testosterone is neither TGA-approved nor PBS-subsidised for age-related testosterone decline, "andropause", anti-ageing or performance optimisation; prescribing for those purposes is off-label and private-pay.
In our AU set
Tracked in Australia
AU clinics
1
Evidence is not approvalAn evidence grade describes how strong the science is. A regulatory status describes whether a body has approved the intervention for an indication. They are different questions, answered separately above.

What it is

Plain-language explainer

Testosterone replacement therapy is the administration of exogenous testosterone, most often as a long-acting intramuscular injection (testosterone undecanoate, 1000 mg every 10 to 14 weeks) or a daily transdermal gel, to men with biochemically confirmed testosterone deficiency. Its established medical purpose is to restore serum testosterone into the eugonadal range in men with hypogonadism arising from testicular, pituitary or hypothalamic disease. In the longevity market it is additionally promoted for men with age-related or borderline-low testosterone as a way to improve body composition, energy, libido, mood and metabolic health, a use that is broader than the indication either regulator has approved.

Categories

Protocol

Offered by

Where variis has verified this protocol (2)

  • ClinicATA Medical (Healthscreening.sg)Singapore, Singapore
  • ClinicAustralian Longevity ClinicBrisbane, Australia

Common questions

What is Testosterone replacement therapy (TRT)?
TRT has genuine randomised human evidence, which puts it well ahead of most longevity clinic offerings, but the evidence supports narrower claims than the marketing does. TRAVERSE (n=5,246 men aged 45 to 80 with hypogonadal symptoms, testosterone under 300 ng/dL, and existing or high cardiovascular risk; NEJM 2023) found daily 1.62% testosterone gel non-inferior to placebo for major adverse cardiac events (7.0% vs 7.3%; HR 0.96, 95% CI 0.78 to 1.17). That is a safety result, not a benefit result: TRAVERSE showed TRT does not appear to raise MACE risk in that population, while also recording small excesses of atrial fibrillation, pulmonary embolism and fracture. The Australian T4DM trial (Wittert et al., Lancet Diabetes & Endocrinology 2021; n=1,007 men aged 50 to 74 with impaired glucose tolerance or new type 2 diabetes and testosterone at or below 14.0 nmol/L, explicitly WITHOUT pathological hypogonadism) found that two years of testosterone undecanoate added to a lifestyle programme cut two-year type 2 diabetes incidence by roughly 40%, with fat loss and strength gains. Notably, T4DM's own lead investigator cautioned that testosterone is not a substitute for lifestyle intervention, and follow-up reporting indicates the diabetes-prevention effect was not durable once treatment stopped. What the evidence does NOT show: no trial has demonstrated that TRT extends lifespan, reduces all-cause mortality, slows biological ageing, or improves any validated healthspan endpoint. There is no RCT evidence supporting testosterone in men with normal testosterone levels, and the long-term effects of decades-long supraphysiological or "optimisation" dosing outside diagnosed deficiency are untested. Fertility suppression is a real and sometimes irreversible consequence. The honest grade is: strong clinical evidence for symptom and metabolic outcomes in confirmed deficiency, no evidence for the longevity claim itself.
How strong is the evidence for Testosterone replacement therapy (TRT)?
Clinical. There is human trial evidence, which is the strongest grade variis applies to a protocol.
Is Testosterone replacement therapy (TRT) approved in Singapore?
Health Sciences Authority position on record: Registered and prescription-only. Testosterone products are registered therapeutic products with HSA and classified as Prescription Only Medicines. Nebido (testosterone undecanoate 1,000 mg/4 mL) holds Singapore registration number SIN13281P, listed on the MOH National Drug Formulary as a Prescription Only Medicine, indicated for testosterone replacement therapy in adult males with testosterone deficiency confirmed by clinical features and biochemical testing. Other registered options in Singapore include testosterone gel and testosterone ester injections. Prescribing requires a licensed medical practitioner and biochemically confirmed deficiency; there is no HSA-approved indication for testosterone as an anti-ageing, performance or longevity-optimisation intervention, so use in men without confirmed deficiency is off-label.. An evidence grade and a regulatory approval are different questions.
Is Testosterone replacement therapy (TRT) approved in Australia?
Therapeutic Goods Administration position on record: Registered on the ARTG and Schedule 4 (prescription-only). Testosterone undecanoate 1,000 mg/4 mL is ARTG-registered as Reandron 1000 (ARTG 106946 ampoule, 213942 vial; sponsor Aspen Pharmacare Australia), with several later generics (Rejunon, Gonadron, Reanmed, Testosterone SUN); transdermal testosterone products are also registered. The TGA-approved indication is testosterone replacement therapy for confirmed testosterone deficiency / male hypogonadism established by clinical features and biochemical tests. PBS subsidy is Authority Required and tightly restricted: androgen deficiency with an established pituitary or testicular disorder, or, for men 40 and over without such a disorder, androgen deficiency confirmed on at least two separate morning blood samples (testosterone below 8 nmol/L, or 8 to 15 nmol/L with elevated LH). Testosterone is neither TGA-approved nor PBS-subsidised for age-related testosterone decline, "andropause", anti-ageing or performance optimisation; prescribing for those purposes is off-label and private-pay.. An evidence grade and a regulatory approval are different questions.
Which clinics offer Testosterone replacement therapy (TRT)?
2 clinics in the variis directory across Singapore and Australia have Testosterone replacement therapy (TRT) on record. Each is listed on this page with its own sourced profile.
What else is Testosterone replacement therapy (TRT) called?
Also known as TRT, androgen replacement, androgen replacement therapy, andropause treatment, male hormone therapy, testosterone therapy, testosterone optimisation.

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Sources

What this profile is built on

  1. NEBIDO SOLUTION [SIN13281P] product information · Singapore National Drug Formulary (MOH)
  2. Testosterone Undecanoate Injection 1g/4ml · HealthHub Singapore (MOH)
  3. How therapeutic products are regulated by HSA · Health Sciences Authority, Singapore
  4. REANDRON 1000 testosterone undecanoate 1000mg in 4mL oily solution for injection ampoule (ARTG 106946) · Therapeutic Goods Administration, Australia
  5. REANDRON 1000 testosterone undecanoate, vial (ARTG 213942) · Therapeutic Goods Administration, Australia
  6. TESTOSTERONE UNDECANOATE - 10205D, Authority Required listing · Pharmaceutical Benefits Scheme, Australia
  7. Testosterone: utilisation analysis (DUSC), restriction criteria · Pharmaceutical Benefits Scheme, Australia
  8. Cardiovascular Safety of Testosterone-Replacement Therapy (TRAVERSE) · New England Journal of Medicine
  9. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM) · The Lancet Diabetes & Endocrinology
  10. Endocrine Society of Australia position statement on male hypogonadism (part 1) · Medical Journal of Australia
  11. Testosterone Replacement Therapy Singapore: Gel & Injection · ATA Medical
  12. Hormone Replacement Therapy (HRT) Singapore · ATA Medical
  13. Australian Longevity Clinic, Brisbane, services including TRT · Australian Longevity Clinic

Last updated 14 August 2026

Every entity profile on variis is sourced. Not medical advice.