AndroGel Safety in Older Adults Ages 50 to 64

Is AndroGel approved for a man in his 50s or 60s?

Testosterone products are FDA-approved only for men who have low testosterone along with an associated medical condition - testicular failure from causes such as genetic problems or chemotherapy, or disease of the hypothalamus or pituitary [3]. None of the approved products is approved for low testosterone in men who lack such a condition [3]. FDA says that in June 2026 it requested removal of the limitation of use stating that safety and efficacy in age-related hypogonadism have not been established, and asked for revised safety information on prostate cancer and benign prostatic hyperplasia [3]. That is a request to sponsors, not a finished label change.

The Endocrine Society recommends diagnosing hypogonadism only in men with symptoms and consistently low testosterone, starting with a fasting morning total testosterone and confirming it with a repeat measurement [5]. For a 55-year-old with fatigue or low libido, the drug question only arises after two low morning values line up with those symptoms [5].

What TRAVERSE showed for men in this age band

TRAVERSE enrolled 5,246 men aged 45 to 80 who reported hypogonadism symptoms, had two fasting testosterone levels below 300 ng/dL, and had existing cardiovascular disease or a high risk of it [1]. Participants received daily transdermal 1.62% testosterone gel, adjusted to keep levels between 350 and 750 ng/dL, or placebo gel [1]. Mean treatment lasted 21.7 months and mean follow-up was 33.0 months [1]. The primary endpoint - cardiovascular death, nonfatal heart attack or nonfatal stroke - occurred in 182 men (7.0%) on testosterone and 190 (7.3%) on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting the noninferiority margin [1]. FDA reviewed the results and said they did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [3].

TRAVERSE tested a gel, not injections, and no outcome trial of that size exists for injectable testosterone [1]. A man of 50 to 64 falls inside the enrolled age range, but the published percentages cover the whole trial rather than that subgroup [1].

Blood pressure is a class warning for every testosterone product

FDA's February 2025 action told testosterone sponsors to add TRAVERSE results to all labels, keep the limitation of use for age-related hypogonadism, remove boxed-warning language about increased cardiovascular risk, and add a blood pressure warning to products that lacked one [2]. FDA also said the completed ambulatory blood pressure monitoring studies confirmed a rise in blood pressure with all testosterone products, class-wide [2].

Hematocrit: the most predictable laboratory effect

Every testosterone form raised hematocrit over placebo in a network meta-analysis of 29 placebo-controlled randomized trials covering 3,393 men: gel by 3.0% (95% CI 1.8 to 4.3), intramuscular enanthate or cypionate by 4.0% (2.9 to 5.1), oral testosterone undecanoate by 4.3%, patch by 1.4% and intramuscular undecanoate by 1.6% [4]. Intramuscular enanthate or cypionate raised hematocrit significantly more than patch; the other head-to-head comparisons, including gel against intramuscular enanthate or cypionate, were not significantly different [4].

A retrospective review of 178 hypogonadal men followed for three years found hematocrit above 50% in 12.8% of men on gels, 35.1% on pellets and 66.7% on injections - but the injection group was younger (mean 42.5 vs about 54 years) with higher baseline hematocrit, and the study was not randomized [6]. A review of testosterone therapy in aging men reported a 315% greater risk of erythrocytosis, defined as hematocrit above 0.52, compared with controls, with injectables highest [7]. The Endocrine Society recommends monitoring hematocrit during the first year of treatment, and recommends against starting therapy in men with elevated hematocrit [5].

Prostate monitoring

The Endocrine Society recommends against starting testosterone therapy in men with breast or prostate cancer, and recommends monitoring prostate cancer risk during the first year of treatment [5]. FDA's June 2026 request to sponsors included revising safety information on prostate cancer and benign prostatic hyperplasia [3].

What is not settled for men aged 50 to 64

The randomized symptom evidence comes from older men. The Testosterone Trials enrolled 790 men aged 65 or older with testosterone below 275 ng/dL for one year: sexual activity increased (P<0.001), sexual desire and erectile function improved, vitality did not improve significantly, and the share of men adding at least 50 m to their six-minute walk differed (20.5% versus 12.6%, P=0.003) only when all three sub-trials were pooled [8]. A coronary plaque sub-study of 170 of those men found a greater increase in noncalcified plaque volume with testosterone over 12 months (estimated difference 41 mm3, 95% CI 14 to 67; P=0.003) [9].

For a man of 55, then, the cardiovascular outcome data include him, while the symptom-benefit data come from men roughly a decade older [1][8].

When not to start

The Endocrine Society recommends against starting testosterone in men with breast or prostate cancer, elevated hematocrit, untreated severe sleep apnea, uncontrolled heart failure, a heart attack or stroke within the previous six months, or plans for fertility in the near term [5].