Who testosterone is approved for
The FDA approves testosterone only for men who lack or have low testosterone together with an associated medical condition: testicular failure (for example from genetic conditions, chemotherapy or injury) or problems in the pituitary or hypothalamus that control the testes. None of the approved products is approved for men with low testosterone and no associated medical condition (FDA).
Approved forms include gels, patches, a buccal system, injections and other formulations, all prescription-only. Treating age-related low testosterone without such a condition has been outside the labeled use; see the June 2026 label request below.
This article is general information, not medical advice or a dosing recommendation. Decisions about starting, changing or stopping a prescription belong with a licensed clinician who knows your history.
How low T is diagnosed
The Endocrine Society recommends diagnosing hypogonadism only in men with symptoms and signs of testosterone deficiency and unequivocally, consistently low testosterone. That means a fasting morning total testosterone measured with an accurate assay, confirmed with a repeat morning test, plus free testosterone when total testosterone is borderline or binding proteins are abnormal, and a workup for the cause (Bhasin et al., JCEM 2018, PMID: 29562364).
The American Urological Association guideline uses a total testosterone below 300 ng/dL as a reasonable cutoff alongside symptoms (Mulhall et al., J Urol 2018, PMID: 29601923). A single afternoon test is not a diagnosis.
What TRAVERSE showed
TRAVERSE was the FDA-required safety trial. It randomized 5,246 men aged 45 to 80 with symptoms, two fasting testosterone levels under 300 ng/dL, and existing or high risk of heart disease, to testosterone gel or placebo (Lincoff et al., NEJM 2023, PMID: 37326322).
| Outcome | Testosterone | Placebo |
|---|---|---|
| Major heart events (CV death, heart attack, stroke) | 7.0% | 7.3% |
| Clinical fractures (substudy, median 3.2 years) | 3.50% | 2.46% |
| Atrial fibrillation, acute kidney injury, pulmonary embolism | Higher incidence | Lower incidence |
The heart-event result met the trial’s non-inferiority test (hazard ratio 0.96). In the fracture substudy, testosterone did not lower fractures and the rate was numerically higher (hazard ratio 1.43) (Snyder et al., NEJM 2024, PMID: 38231621).
Symptom benefits in trials were modest. In the Testosterone Trials, men 65 and older with low testosterone got moderate benefit in sexual function and some in mood, but no benefit in vitality (energy) or walking distance (Snyder et al., NEJM 2016, PMID: 26886521).
What changed on the labels, 2025–2026
February 2025. After TRAVERSE and ambulatory blood-pressure studies, the FDA told manufacturers to add TRAVERSE results to every testosterone label, remove boxed-warning language about increased cardiovascular risk, keep the limitation of use for age-related hypogonadism at that time, and add a warning that testosterone can raise blood pressure (FDA). In TRAVERSE, the gel raised systolic pressure by a mean 1.5 mm Hg more than placebo at 36 months (Testim label, DailyMed).
June 2026. The FDA requested further updates: removing the limitation-of-use statement that safety and efficacy have not been established for age-related hypogonadism, and revising the information on prostate cancer and benign prostatic hyperplasia (FDA). Labels change product by product as manufacturers submit updates, so check the current label for any specific product.
Testosterone gels still carry a boxed warning about secondary exposure: children have shown virilization after contact with unwashed or unclothed application sites (Testim label).
Monitoring guidelines describe
The Endocrine Society recommends a standardized monitoring plan: symptoms, side effects and adherence; serum testosterone (aiming for the mid-normal range); hematocrit; and prostate cancer risk evaluation during the first year (Bhasin et al., 2018). Labels add periodic PSA, hematocrit, lipid and blood pressure checks (Testim label).
Ask any online clinic which baseline labs it orders, how often it repeats them, and what it does if hematocrit rises.
Fertility: the side effect people miss
Outside testosterone signals the brain to cut LH and FSH, the hormones that drive sperm production. Labels warn that exogenous androgens may lead to azoospermia (no sperm in the ejaculate) (Testim label), and the Endocrine Society recommends against starting TRT in men planning fertility in the near term (Bhasin et al., 2018).
Men who want children soon usually discuss alternatives that keep the body’s own production running. We compare one in enclomiphene vs TRT.
Safety: who should not start TRT
The Endocrine Society recommends against starting testosterone in men with any of these (Bhasin et al., 2018):
• Breast or prostate cancer, a palpable prostate nodule, or a PSA above 4 ng/mL (above 3 in higher-risk men) without urologic evaluation
• Elevated hematocrit, untreated severe obstructive sleep apnea, or severe lower urinary tract symptoms
• Uncontrolled heart failure, a heart attack or stroke in the last 6 months, or a clotting disorder (thrombophilia)
• Plans to father a child soon
Labels also list blood clots, swelling with heart, kidney or liver disease, and worsening sleep apnea among the risks, and say testosterone is not recommended with uncontrolled high blood pressure. Testosterone is prohibited in tested sport (WADA).
This article is general information, not medical advice or a dosing recommendation. Decisions about starting, changing or stopping a prescription belong with a licensed clinician who knows your history.
Comparing TRT providers and costs
Our TRT comparison scores approved partners on monthly cost, what is included (labs, visits) and trust signals. See also online TRT clinics compared, what TRT costs online and our MangoRx review.
Disclosure
CalcMyPeptide may earn commissions from some telehealth providers on our comparison and review pages, which list only vetted providers whose affiliate programs have approved us or are reviewing our application. This article contains no paid links. How we rank providers and get paid: telehealth disclosure and methodology.