TRT for Men Over 60: What the Big Trials Actually Showed

The Short Answer

Why the Over-60 Question Is Different

Testosterone labels were written for men whose low testosterone has a known cause, such as testicular failure or pituitary disease. Low testosterone that shows up with age, without a structural cause, sits in a gray zone. The current Jatenzo label on DailyMed still says safety and efficacy in men with "age-related hypogonadism" have not been established.

That may change. On June 18, 2026, the FDA requested label updates that would remove that limitation and narrow the prostate cancer contraindication to men with metastatic disease. Those are requested changes, not final ones. As of October 2026, the Jatenzo and Kyzatrex labels we checked still carried both the age-related limitation and the "known or suspected" prostate cancer contraindication. (Kyzatrex's label does show that a separate contraindication for hypogonadism without a structural or genetic cause was removed in July 2025.)

Separately, in April 2026 the FDA invited manufacturers to pursue a possible new indication for low libido in men with idiopathic hypogonadism. We cover that in our piece on the FDA's libido signal.

None of this stops a prescriber from treating an older man with confirmed low testosterone. It does tell you the evidence is still being argued over, which is why the trial details below are worth knowing.

Diagnosis rules don't loosen with age. The American Urological Association guideline calls for two total testosterone measurements on separate early mornings and treats 300 ng/dL as a reasonable cutoff. Older men also have a flatter daily rhythm: in one study, men around 70 showed only about a 10% morning-to-afternoon decline, versus 20–25% in men aged 30 to 40 (Brambilla et al., 2009). See the two-test rule for how to get draws that hold up.

What the Testosterone Trials Found in Men 65 and Older

The Testosterone Trials (TTrials), published in the New England Journal of Medicine in 2016, are still the most direct evidence for this age group. Researchers randomized 790 men aged 65 or older with testosterone below 275 ng/dL to testosterone gel (starting at 5 g daily) or placebo gel for one year.

Sources: the main NEJM paper, the bone trial in JAMA Internal Medicine, and the investigators' 2018 Endocrine Reviews summary.

Two safety signals appeared within a single year. Seven men on testosterone reached a hemoglobin of 17.5 g/dL or higher, versus none on placebo. And 23 men on testosterone had a PSA rise of 1.0 ng/mL or more, versus 8 on placebo. The authors said the trials were too small to judge treatment risks, which is the gap TRAVERSE was built to fill.

What TRAVERSE Added: Heart, Prostate and Fractures

TRAVERSE randomized 5,246 hypogonadal men aged 45 to 80 with cardiovascular disease or multiple risk factors. Men used 1.62% testosterone gel or placebo, and the average participant was 63, per the trial's prostate safety report. The outcome figures below come from the FDA-approved testosterone gel labeling that now summarizes the trial, which counts 5,198 men in its safety set.

• Heart attack, stroke or cardiovascular death: 7.0% on testosterone vs 7.3% on placebo (hazard ratio 0.96), meeting the trial's non-inferiority goal.
• Rhythm, kidneys and clots: more nonfatal arrhythmias needing intervention (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and pulmonary embolism (0.9% vs 0.5%).
• Prostate: high-grade prostate cancer in 0.19% vs 0.12%, a difference that wasn't statistically significant. Men with a PSA above 3.0 ng/mL were excluded, so this reassures screened men, not everyone.
• Fractures: after a median 3.19 years, clinical fractures occurred in 3.50% of men on testosterone vs 2.46% on placebo (hazard ratio 1.43; 95% CI 1.04–1.97), per the NEJM fracture analysis.
• Anemia: among 815 men who started with anemia, it was corrected at six months in 41.0% on testosterone vs 27.5% on placebo (JAMA Network Open, 2023).

The fracture result surprised people because the TTrials showed denser bone. The practical point: testosterone is not a fracture-prevention drug. If you have osteoporosis, it needs its own treatment plan. Our bone density deep-dive covers the long-term data, and TRAVERSE explained walks through the full trial.

After TRAVERSE, the FDA in February 2025 removed the cardiovascular-outcomes language from the boxed warning on testosterone products and added a blood pressure warning. On the Testim gel label, ambulatory monitoring showed average blood pressure rising 2.7/1.1 mm Hg after 16 weeks.

What the Guidelines Say About Older Men

Endocrine Society (2018)

The Endocrine Society suggests against routinely prescribing testosterone to all men 65 or older. For men over 65 who have symptoms and consistently low morning testosterone, it says to offer treatment on an individualized basis after discussing risks and benefits.

It also lists conditions that argue against starting, several of which become more common after 60: a PSA above 4 ng/mL (or above 3 ng/mL with high prostate cancer risk) without urologic evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, uncontrolled heart failure, and a heart attack or stroke in the last six months.

American College of Physicians (2020)

The ACP guideline on age-related low testosterone is narrower. Clinicians should discuss starting testosterone with men who have sexual dysfunction and want to improve it, reevaluate symptoms within 12 months, and stop if sexual function doesn't improve. ACP advises against starting testosterone to improve energy, vitality, physical function or cognition.

ACP also suggests considering injections over gels because of cost. Using 2016 Medicare Part D data, it reported an annual cost per beneficiary of $2,135.32 for transdermal testosterone versus $156.24 for intramuscular.

Target levels

Both groups aim for the middle of the normal range, not the top. The Endocrine Society says mid-normal; the AUA guideline describes the middle tertile as roughly 450–600 ng/dL for most labs.

Monitoring Priorities After 60

The trial signals above point to a short list of things to watch. The schedules below come from the Endocrine Society's monitoring plan and current FDA labeling; your prescriber may test more often.

One wrinkle on PSA: the U.S. Preventive Services Task Force recommends against PSA-based screening in men 70 and older (a 2018 recommendation the Task Force is updating), while the Endocrine Society says that after the first year of TRT, prostate monitoring should follow standard screening guidelines. Ask your prescriber how they'll handle PSA at your age. Our PSA and TRT guide covers what a rise means. For lipids, see TRT and cholesterol.

Questions to Ask Before Starting After 60

1. Were both of my tests early-morning draws below the lab's cutoff?
2. Which symptom are we treating, and how will we judge it at the 12-month mark ACP recommends?
3. Gel or injection? ACP's 2016 Medicare figures put gels at far higher cost, and gel labels such as Testim's carry a boxed warning about virilization in children who were secondarily exposed. That matters if grandchildren visit.
4. What is my PSA plan, given my age and history?
5. How will you track hematocrit, blood pressure and heart rhythm, and what results would make you lower the dose or pause?
6. Do my current medications, especially blood thinners, diabetes drugs or steroids, need extra monitoring?
7. If my bone density is low, what is my separate plan for fracture prevention?

If you're weighing an online clinic, check what it requires before prescribing. TRT Nation, for example, requires total testosterone, CBC, CMP, sensitive estradiol and, for men over 40, a PSA. That's a reasonable floor; an older man with heart or kidney history may need more.

The Bottom Line

After 60, TRT is a reasonable option for a specific problem, mainly low sexual desire or function with confirmed low testosterone, and a weak option for fatigue, strength or memory. TRAVERSE eased much of the heart-attack worry, but it added reasons to watch heart rhythm, clots, kidneys and fractures.

Next steps: get two early-morning tests, agree with your prescriber on what success looks like at 12 months, and settle the monitoring schedule before the first dose. If you're already on TRT and thinking about the decades ahead, read our take on stopping at 70. Not sure what kind of clinic fits? The clinic-matching quiz takes a few minutes.