Testosterone replacement therapy
Also called: TRT
Clinical reviewer: Jacob Moore, MD · Last checked September 16, 2026
What is TRT?
Testosterone replacement therapy is prescription testosterone, a steroid hormone rather than a peptide, given to men whose bodies produce too little of it. FDA approves it only for men who lack or have low testosterone alongside an associated medical condition, and label language limiting its use for age-related low testosterone remains in place.
What does FDA approve TRT for?
Testosterone products are "approved solely for use in men who lack or have low testosterone levels in conjunction with an associated medical condition" [1]. A representative label, Depo-Testosterone, lists primary and hypogonadotropic hypogonadism as its indications and states that safety and efficacy for "age-related hypogonadism" have not been established [3]. FDA is "retaining 'Limitation of Use' language for age-related hypogonadism" in its February 2025 labeling update, keeping that boundary in place [1].
What changed on TRT labels in 2025?
TRAVERSE, a randomized, placebo-controlled trial of 5,246 men aged 45 to 80 with hypogonadism symptoms and low testosterone, found "no increase in the risk of adverse cardiovascular outcomes" over a mean 33-month follow-up, with the primary event occurring in 7.0% of the testosterone group versus 7.3% on placebo [1][2]. Based on that result, FDA is "removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products," while adding "a new warning about increased blood pressure" drawn from ambulatory blood-pressure monitoring studies [1]. TRAVERSE did record more atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group [2].
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This entry is for education and is not medical advice. Talk with a licensed clinician about your own situation before starting, stopping, or changing any treatment.
