AndroGel Safety in Young Adults (Ages 18 to 29): What You Need to Know Before Starting

Is AndroGel approved for a man in his 20s?

The AndroGel 1% label covers replacement therapy in adult males with primary hypogonadism (testicular failure from causes such as Klinefelter syndrome, undescended testis, torsion, orchitis, removal of the testes, chemotherapy, or toxic damage from alcohol or heavy metals) or hypogonadotropic hypogonadism (gonadotropin or LHRH deficiency, or pituitary or hypothalamic injury from tumor, trauma or radiation) [1]. Age 18 and over is not a barrier in itself, but a diagnosis is. Safety and efficacy in males younger than 18 have not been established, and the label says improper use may result in acceleration of bone age and premature closure of epiphyses in pediatric patients [1].

FDA puts the same point more bluntly: none of the approved testosterone products are approved for men with low testosterone who lack an associated medical condition [2]. The AndroGel 1% label also carries a limitation of use saying safety and efficacy in age-related hypogonadism have not been established [1]. In June 2026 FDA asked sponsors to remove that limitation and to revise prostate cancer and benign prostatic hyperplasia safety information; that is a request, and the AndroGel 1% label in effect since July 2025 still carries the limitation [1][2].

The diagnosis the label requires is serum testosterone measured in the morning on at least two separate days, both results below the normal range [1]. That is not the same as the 300 ng/dL cutoff used to enroll men in TRAVERSE [3].

AndroGel 1.62% was used in TRAVERSE [2][3]. The AndroGel 1% label says its dosage and administration differ from AndroGel 1.62% [1].

Fertility is the main documented risk at this age

The label lists the potential for adverse effects on spermatogenesis in its warnings: exogenous administration of androgens may lead to azoospermia, and with large doses spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone [1]. Its fertility section goes further, stating that reduced fertility is observed in some men taking testosterone replacement therapy, that testicular atrophy, subfertility and infertility have been reported in men who abuse anabolic androgenic steroids, and that with either type of use the impact on fertility may be irreversible [1].

Evidence on sperm recovery comes from hormonal male contraception studies in healthy men and from studies of men with infertility after testosterone use [4][5][6].

• An integrated analysis of 30 hormonal male contraception studies followed 1,549 healthy men with normal reproductive function, aged 18 to 51, on androgen or androgen-progestin regimens. Median time for sperm concentration to recover to 20 million per mL was 3.4 months; recovery reached 67% by 6 months, 90% by 12 months, 96% by 16 months and 100% by 24 months. Recovery was faster with shorter-acting testosterone, shorter treatment, older age and a higher baseline sperm count [4].
• A case series of 49 men with azoospermia or severe oligospermia while on testosterone treated them with hCG 3,000 units subcutaneously every other day plus clomiphene, tamoxifen, anastrozole or recombinant FSH. Spermatogenesis returned or improved in 47 men (95.9%), with an average time of 4.6 months and a mean first sperm density of 22.6 million per mL [5].
• A retrospective study of 66 men with infertility after testosterone use who stopped testosterone and received high-dose hCG plus a selective estrogen receptor modulator found that 46 (70%) reached a total motile count above 5 million within 12 months. That included 64.8% of men who had been azoospermic and 91.7% of men who had been cryptozoospermic, and both older age and longer testosterone use predicted slower recovery [6].

The Endocrine Society guideline recommends against starting testosterone therapy in men who are planning fertility in the near term, and also in men with breast or prostate cancer, elevated hematocrit, untreated severe sleep apnea, uncontrolled heart failure, or a heart attack or stroke within the past 6 months [7].

Blood pressure and hematocrit: the two monitoring items the label stresses

The label says AndroGel 1% can increase blood pressure, that this can raise cardiovascular risk over time, and to monitor blood pressure periodically, especially in men with hypertension [1]. It reports an ambulatory blood pressure study in which 169 men with usable recordings had a mean 24-hour systolic/diastolic rise of 1.9/1.3 mm Hg at week 16; in men with hypertension who were already on blood pressure medicine the rise was 3.0/2.2 mm Hg [1]. In TRAVERSE, mean systolic pressure rose 1.0 mm Hg on testosterone gel by 36 months against a 0.5 mm Hg fall on placebo, a between-group difference of 1.5 mm Hg [1]. FDA's 2025 class-wide labeling action added a blood pressure warning to products that lacked one and stated that ambulatory monitoring studies confirmed a blood pressure increase with all testosterone products [8].

Hematocrit is the other routine check. The label says to check hematocrit before starting, that it would be appropriate to re-evaluate it 3 to 6 months after starting and then annually, and to stop therapy until hematocrit falls if it becomes elevated [1]. A network meta-analysis of 29 placebo-controlled randomized trials in 3,393 men found gel raised mean hematocrit by 3.0% (95% CI 1.8 to 4.3) versus placebo, while intramuscular enanthate or cypionate raised it by 4.0% (95% CI 2.9 to 5.1) [9]. A retrospective review of 178 men on a single formulation for 3 years found erythrocytosis (hematocrit above 50%) in 12.8% of men on gels versus 66.7% on injectable testosterone; the injection group was younger with a higher baseline hematocrit, and the study was not randomized [10]. A separate review defined erythrocytosis as a hematocrit above 0.52 and calculated a 315% greater risk in men on testosterone replacement than in controls [11].

Cardiovascular risk: what TRAVERSE does and does not tell a 25-year-old

TRAVERSE randomized 5,246 men aged 45 to 80 with hypogonadism and existing or high risk of cardiovascular disease to daily testosterone gel 1.62% or placebo gel [3]. The primary endpoint of cardiovascular death, nonfatal heart attack or nonfatal stroke occurred in 7.0% on testosterone and 7.3% on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority. Mean treatment lasted 21.7 months and follow-up 33 months, and about 61% of participants stopped study gel or placebo early [3]. The label reports venous thromboembolism was numerically higher on testosterone gel, 1.7% versus 1.2%, including deep vein thrombosis at 0.6% versus 0.5% and pulmonary embolism at 0.9% versus 0.5% [1].

FDA reviewed those results and concluded TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [2]. In February 2025, FDA recommended adding TRAVERSE results to testosterone labels and removing boxed-warning language about adverse cardiovascular outcomes [8]. AndroGel 1% has a boxed warning about secondary exposure to children [1].

TRAVERSE enrolled men ages 45 to 80, so it does not directly answer the long-term cardiovascular safety question for men in their twenties [3]. No outcome trial of the same size exists for injectable testosterone [3].

Secondary exposure: the gel's boxed warning

The boxed warning on AndroGel 1% is about other people, not the patient. Virilization has been reported in children who were secondarily exposed to testosterone gel, and children should avoid contact with unwashed or unclothed application sites [1]. Reported signs have included enlargement of the penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age. In most cases these signs regressed once exposure was removed, but in a few, enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than chronological age [1].

The label also states the gel is contraindicated in women who are pregnant and can cause virilization of the female fetus, and that pregnant women need to be aware of the potential for transfer from treated men [1]. Its administration instructions call for washing hands after application, covering the application site with clothing once the gel has dried, and washing the site with soap and water before any situation where skin-to-skin contact is anticipated [1]. The gel is flammable until dry [1].

Bone: does the gel protect it?

Men with hypogonadism can start with low bone density. In one study of 23 men with idiopathic hypogonadotropic hypogonadism, cortical and spinal bone density were both significantly below normal, and the deficit was equally severe in men with immature and mature bone age [12].

Whether testosterone raises bone density depends on the formulation studied. A meta-analysis of 8 randomized placebo-controlled trials in 365 men found intramuscular testosterone produced an 8% (95% CI 4% to 13%) gain in lumbar bone mineral density, while transdermal testosterone had no significant impact; the femoral neck result was a nonsignificant 4% gain, and no trials measured or reported fractures [13].

Dosing and monitoring in the AndroGel 1% label

The label's starting dose of AndroGel 1% is 50 mg of testosterone once daily in the morning, as two 25 mg packets or one 50 mg packet, applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen, and not to the genitals, chest, armpits, knees or back [1]. The dose may be increased to 75 mg or 100 mg if serum testosterone is below the normal range, and the label says that if levels consistently exceed the normal range at 50 mg daily, therapy should be discontinued [1].

The label directs periodic monitoring of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipid concentrations [1]. In a 3-year extension study of 162 men, 18% met a protocol criterion for PSA increase (more than twice baseline or any single PSA above 6 ng/mL), and most first crossed that threshold by month 12 [1].

Rules that apply outside the clinic

Testosterone is a Schedule III controlled substance, and AndroGel 1% is labeled CIII [1]. In WADA-governed sport, anabolic agents including testosterone are prohibited at all times in and out of competition, and a prescription does not make them permitted; an athlete needs a Therapeutic Use Exemption [14].