Living evidence page · Health & function
Testosterone
Released trials separate cardiovascular noninferiority, fracture outcomes and physical-function tests in selected men with symptoms and repeatedly low testosterone. They do not establish anti-aging benefit, general eligibility, healthspan or longer life.
Safety and regulatory context: Released coverage keeps trial-specific safety events, fracture outcomes, one-year limits and dated FDA labeling separate. Treatment for diagnosed hypogonadism is a different question from anti-aging use; this page does not diagnose eligibility or recommend changing therapy.
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Three different evidence questions
Counts and order describe what More Years has released. They do not indicate evidence strength, efficacy, safety, importance, popularity or recommendation.
Released reporting
What the covered evidence says
Large randomized trial · Human cardiovascular outcomes · large randomized noninferiority trial
TRAVERSE found cardiovascular noninferiority—not a longevity benefit
- Population
- 5,246 men age 45–80 with symptoms, repeatedly low testosterone and preexisting or high cardiovascular risk
- Measured
- major cardiovascular events and cardiovascular safety outcomes
Among selected men with hypogonadism and elevated cardiovascular risk, testosterone gel was noninferior to placebo for major cardiovascular events; the trial did not test longer life or general anti-aging use.
Does not establish: The result does not prove cardiovascular benefit, overall safety, safety beyond the observed follow-up, or applicability to men without symptoms and repeated low measurements. It does not apply automatically to injections, pellets, oral products, compounded products, bodybuilding use or supraphysiologic dosing.
Published 2026-08-03 · verified 2026-08-03
Randomized trial · Human fracture and bone-density outcomes · randomized trials
Testosterone did not prevent fractures in TRAVERSE
- Population
- 5,204 TRAVERSE participants: middle-aged and older men with symptoms, repeatedly low testosterone and preexisting or high cardiovascular risk
- Measured
- clinical fractures and bone-density measures
Clinical fractures were more frequent with testosterone than placebo in TRAVERSE; a smaller substudy’s bone-density gain cannot substitute for fracture outcomes.
Does not establish: The analysis does not establish why fractures were higher, identify a causal pathway, or show the same result for every formulation and population. It does not erase appropriate treatment for diagnosed conditions or provide an individual risk estimate.
Published 2026-08-03 · verified 2026-08-03
Randomized trial · Human physical-function outcomes · one-year randomized trials
Testosterone’s walking result was modest—not an anti-aging effect
- Population
- 790 symptomatic men age 65 or older with repeatedly low testosterone; 390 enrolled in the Physical Function Trial
- Measured
- six-minute walking distance and a 50-meter improvement threshold
The prespecified Physical Function Trial threshold was not significant in its enrolled subgroup; broader secondary walking results do not establish disability prevention, healthspan or longevity.
Does not establish: The trials do not establish frailty reversal, prevention of mobility disability, dementia prevention, slower biological aging, healthspan extension or lifespan extension. Results do not automatically apply to younger men, men without symptoms and repeated low values, or other formulations and dosing patterns.
Published 2026-08-03 · verified 2026-08-03
Primary publications and governing syntheses
7 covered studies
These records preserve identifiers, populations, outcomes and interpretation boundaries from the released evidence library.
Randomized trial · peer-reviewed
Ttrials Bone
DOI: 10.1001/jamainternmed.2016.9539
- Population
- 211 men age 65 or older with two low testosterone measurements in the Testosterone Trials
- Measured
- One-year volumetric bone mineral density and estimated bone strength
- Result in released coverage
- In a 211-person Testosterone Trials substudy, one year of testosterone increased spine trabecular volumetric BMD 7.5% versus 0.8% with placebo, a 6.8-percentage-point treatment effect, and increased estimated spine strength. · An improvement in bone-density or estimated-strength surrogates cannot be substituted for the later randomized clinical-fracture outcome.
- Evidence maturity
- large randomized clinical-fracture evidence contrasted with an earlier small one-year bone-density surrogate substudy
- Funding / conflicts
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure. The Testosterone Trials were principally publicly supported, with study product and additional support disclosed by investigators; the trials were not large or long enough for broad safety conclusions.
- Limitations
- One-year volumetric BMD and estimated strength are surrogate measurements in a small substudy; they are not clinical fractures and cannot establish disability, healthspan, or lifespan benefit.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Randomized trial · peer-reviewed
Ttrials Main
DOI: 10.1056/NEJMoa1506119
- Population
- 790 symptomatic men age 65 or older with two morning testosterone concentrations averaging below 275 ng/dL
- Measured
- Sexual function, six-minute walk physical function, vitality, mood, and short-term safety over one year
- Result in released coverage
- The Testosterone Trials enrolled 790 symptomatic men age 65 or older with two morning testosterone concentrations averaging below 275 ng/dL and treated them with monitored 1% gel or placebo for one year. · Among men enrolled in the Physical Function Trial, the primary threshold of increasing six-minute walk distance by at least 50 meters did not differ significantly; odds ratio 1.42, P=0.20. · Across all Testosterone Trials participants, 20.5% assigned testosterone and 12.6% assigned placebo improved six-minute walk distance by at least 50 meters, P=0.003. · Across all participants, the mean between-group six-minute walk-distance difference was 6.69 meters; secondary analyses describe the mobility effect as modest and found no difference in falls. · Testosterone produced a moderate sexual-function benefit but no significant benefit on the Vitality Trial primary endpoint; these domains must not be bundled into a general rejuvenation claim. · The one-year Testosterone Trials do not establish frailty reversal, disability prevention, dementia prevention, healthspan extension, or lifespan extension, and were too small for broad long-term safety conclusions.
- Evidence maturity
- human randomized evidence for domain-specific function outcomes, with no direct disability, healthspan, mortality, or lifespan endpoint
- Funding / conflicts
- The Testosterone Trials were principally publicly supported, with study product and additional support disclosed by investigators; the trials were not large or long enough for broad safety conclusions.
- Limitations
- Applies to selected symptomatic men age 65 or older with repeated low testosterone treated with monitored 1% gel for one year; modest functional results do not establish disability prevention or anti-aging efficacy.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Randomized trial · peer-reviewed
Traverse Cardiovascular
DOI: 10.1056/NEJMoa2215025
- Population
- 5,246 men age 45 to 80 with symptoms, two fasting testosterone values below 300 ng/dL, and preexisting or high cardiovascular risk
- Measured
- Time to cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
- Result in released coverage
- TRAVERSE enrolled 5,246 men age 45 to 80 with hypogonadal symptoms, two fasting testosterone concentrations below 300 ng/dL, and preexisting or high cardiovascular risk. · The primary MACE outcome occurred in 182 of 2,601 men (7.0%) assigned testosterone and 190 of 2,603 (7.3%) assigned placebo; hazard ratio 0.96, 95% CI 0.78 to 1.17. · TRAVERSE met its prespecified cardiovascular noninferiority criterion because the upper 95% confidence boundary was below 1.5; this does not show cardiovascular benefit. · TRAVERSE reported mean treatment duration of about 21.7 months and mean follow-up of about 33 months, limiting inference about very-long-term safety. · Atrial fibrillation, acute kidney injury, and pulmonary embolism occurred more often in the testosterone group; the report does not by itself establish a named causal mechanism. · TRAVERSE was funded by AbbVie and other testosterone manufacturers in an FDA-required postmarketing program, with the sponsor role disclosed in the primary report. · Cardiovascular noninferiority in TRAVERSE does not establish mortality benefit, disability prevention, healthspan extension, or lifespan extension.
- Evidence maturity
- large human randomized noninferiority evidence for one cardiovascular composite, with limited duration and separate safety signals
- Funding / conflicts
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure.
- Limitations
- Applies to selected symptomatic men age 45 to 80 with two fasting low-testosterone measurements, elevated cardiovascular risk, monitored transdermal 1.62% gel, and about 33 months mean follow-up; it does not establish every safety outcome or longer-term effects.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Randomized trial · peer-reviewed
Traverse Fracture
DOI: 10.1056/NEJMoa2308836
- Population
- 5,204 TRAVERSE participants with adjudicated clinical-fracture follow-up
- Measured
- Time to first clinical fracture over median 3.19 years
- Result in released coverage
- The TRAVERSE fracture analysis included 5,204 participants and followed them for a median 3.19 years. · A clinical fracture occurred in 91 of 2,601 participants (3.50%) assigned testosterone and 64 of 2,603 (2.46%) assigned placebo; hazard ratio 1.43, 95% CI 1.04 to 1.97. · Testosterone treatment did not reduce clinical fractures in TRAVERSE; fracture incidence was higher in the testosterone group. · An improvement in bone-density or estimated-strength surrogates cannot be substituted for the later randomized clinical-fracture outcome. · The fracture result does not establish why fractures were higher and does not justify a specific mechanistic, disability, healthspan, or lifespan claim.
- Evidence maturity
- large randomized clinical-fracture evidence contrasted with an earlier small one-year bone-density surrogate substudy
- Funding / conflicts
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure. The Testosterone Trials were principally publicly supported, with study product and additional support disclosed by investigators; the trials were not large or long enough for broad safety conclusions.
- Limitations
- Applies to the adjudicated TRAVERSE fracture substudy over median 3.19 years; it does not identify why fractures differed or establish effects for other formulations, populations, or longer follow-up. · One-year volumetric BMD and estimated strength are surrogate measurements in a small substudy; they are not clinical fractures and cannot establish disability, healthspan, or lifespan benefit.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Other human evidence · peer-reviewed
Ttrials Walking Secondary
PMID: 30366567
- Population
- Testosterone Trials participants with and without enrollment in the Physical Function Trial
- Measured
- Six-minute walk distance, self-reported walking ability, and falls
- Result in released coverage
- Across all participants, the mean between-group six-minute walk-distance difference was 6.69 meters; secondary analyses describe the mobility effect as modest and found no difference in falls. · The one-year Testosterone Trials do not establish frailty reversal, disability prevention, dementia prevention, healthspan extension, or lifespan extension, and were too small for broad long-term safety conclusions.
- Evidence maturity
- human randomized evidence for domain-specific function outcomes, with no direct disability, healthspan, mortality, or lifespan endpoint
- Funding / conflicts
- The Testosterone Trials were principally publicly supported, with study product and additional support disclosed by investigators; the trials were not large or long enough for broad safety conclusions.
- Limitations
- Applies to selected symptomatic men age 65 or older with repeated low testosterone treated with monitored 1% gel for one year; modest functional results do not establish disability prevention or anti-aging efficacy.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Other human evidence · publication record
Fda Traverse Label Review
Source: fda-testosterone-labeling-2025
- Population
- FDA class-wide review of testosterone products using TRAVERSE and postmarket ambulatory blood-pressure studies
- Measured
- Cardiovascular boxed-warning language and class-wide blood-pressure warnings
- Result in released coverage
- On February 28, 2025, FDA said TRAVERSE supported removing cardiovascular-risk language from the boxed warning while ambulatory blood-pressure studies supported class-wide blood-pressure warnings; that notice retained the age-related-hypogonadism limitation at that time.
- Evidence maturity
- large human randomized noninferiority evidence for one cardiovascular composite, with limited duration and separate safety signals
- Funding / conflicts
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure.
- Limitations
- Regulatory language is dated, product-specific prescribing information may differ, and a label revision is neither a treatment recommendation nor evidence of longevity benefit.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Other human evidence · publication record
Fda 2026 Label Review
Source: hhs-testosterone-labels-2026
- Population
- FDA and HHS review of testosterone-replacement-therapy prescribing information
- Measured
- Requested limitation-of-use, prostate-cancer, and benign-prostatic-hyperplasia label revisions
- Result in released coverage
- On June 18, 2026, HHS announced FDA-requested removal of the age-related-hypogonadism limitation-of-use language and revisions to prostate-cancer and benign-prostatic-hyperplasia information.
- Evidence maturity
- large human randomized noninferiority evidence for one cardiovascular composite, with limited duration and separate safety signals
- Funding / conflicts
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure.
- Limitations
- Regulatory language is dated, product-specific prescribing information may differ, and a label revision is neither a treatment recommendation nor evidence of longevity benefit.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Registry records
2 connected clinical trials
Status and results availability are kept separate from evidence conclusions.
Completed · Registry results posted
testosterone — NCT00799617
- Population
- 5,204 TRAVERSE participants: middle-aged and older men with symptoms, repeatedly low testosterone and preexisting or high cardiovascular risk
- Intervention / comparator
- randomized trials
- Primary outcome
- clinical fractures and bone-density measures
- Sponsor / funding context
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure. The Testosterone Trials were principally publicly supported, with study product and additional support disclosed by investigators; the trials were not large or long enough for broad safety conclusions.
Registry status is operational information, not evidence of benefit.
Status checked 2026-08-03 · registry link checked 2026-08-27
Completed · Registry results posted
testosterone — NCT03518034
- Population
- 5,204 TRAVERSE participants: middle-aged and older men with symptoms, repeatedly low testosterone and preexisting or high cardiovascular risk
- Intervention / comparator
- randomized trials
- Primary outcome
- clinical fractures and bone-density measures
- Sponsor / funding context
- TRAVERSE was an FDA-required postmarketing trial funded by an industry consortium led by AbbVie; sponsor and investigator roles require visible disclosure. The Testosterone Trials were principally publicly supported, with study product and additional support disclosed by investigators; the trials were not large or long enough for broad safety conclusions.
Registry status is operational information, not evidence of benefit.
Status checked 2026-08-03 · registry link checked 2026-08-27
Coverage timeline
When this reporting was released
- TRAVERSE found cardiovascular noninferiority—not a longevity benefitHuman cardiovascular outcomes · large randomized noninferiority trial
- Testosterone did not prevent fractures in TRAVERSEHuman fracture and bone-density outcomes · randomized trials
- Testosterone’s walking result was modest—not an anti-aging effectHuman physical-function outcomes · one-year randomized trials