AndroGel for Male Hypogonadism: Evidence, Dosing, and What to Expect

What male hypogonadism means

The generic testosterone gel 1% label divides hypogonadism into two patterns. In primary hypogonadism the testicles fail, from cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals, and FSH and LH usually run above the normal range. In hypogonadotropic (secondary) hypogonadism the cause is gonadotropin or LHRH deficiency, or pituitary or hypothalamic injury from tumor, trauma or radiation, and gonadotropins are normal or low [9].

Both major guidelines require symptoms plus more than one low number. The Endocrine Society says to diagnose hypogonadism only in men with symptoms and signs consistent with testosterone deficiency and unequivocally and consistently low serum testosterone, starting with a fasting morning total testosterone on an accurate assay and confirming it by repeating the measurement; free testosterone by equilibrium dialysis or an accurate formula is added when the total is near the lower limit of normal or SHBG is altered [4]. The AUA uses a total testosterone below 300 ng/dL as a reasonable cutoff and requires two early-morning measurements on separate occasions [5]. For context, the harmonized range in healthy non-obese men aged 19 to 39 was 264 to 916 ng/dL (2.5th to 97.5th percentile) across 9,054 men in four cohorts, and assay differences accounted for much of the variation between cohorts [8].

FDA's position is narrower than low testosterone. Approved testosterone products are for men who lack or have low testosterone together with an associated medical condition, such as testicular failure from genetic problems or chemotherapy, or hypothalamus or pituitary problems, and FDA states that none of the approved products is for men with low testosterone who lack such a condition [1]. The labels checked still carry a Limitation of Use saying safety and efficacy in age-related or late-onset hypogonadism have not been established; in June 2026 FDA asked manufacturers to remove that limitation and to revise prostate cancer and benign prostatic hyperplasia safety information, and FDA's page does not confirm that each label has been updated [1].

Is AndroGel approved for hypogonadism?

Yes, for that defined group. AndroGel 1% is approved under NDA 021015, first approved on 28 February 2000 [3]. FDA identifies AndroGel 1.62% as the testosterone treatment given in TRAVERSE [1], and topical gel is among the formulations FDA lists as approved [1].

The regulatory picture has moved recently. FDA's 28 February 2025 class-wide action called for the TRAVERSE results to be added to testosterone labeling, kept the Limitation of Use for age-related hypogonadism, called for removal of language about an increased risk of adverse cardiovascular outcomes from the Boxed Warning of testosterone products, and called for blood pressure warnings after ambulatory monitoring studies confirmed a blood pressure increase with all testosterone products [6]. FDA reviewed TRAVERSE and concluded it did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [1].

How is AndroGel taken?

AndroGel is a topical gel, one of the formulations FDA lists among approved testosterone products alongside the transdermal patch, a buccal system applied to the upper gum or inner cheek, and injection [1]. In TRAVERSE the 1.62% gel was applied once daily and the dose adjusted to keep serum testosterone between 350 and 750 ng/dL [2]. The Endocrine Society recommends aiming for mid-normal testosterone concentrations with any approved formulation [4].

The generic testosterone gel 1% label says topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure, and that its dosage and administration differ from testosterone gel 1.62% [9].

What the trials show

The Testosterone Trials randomized 790 men aged 65 or older with serum testosterone below 275 ng/dL and symptoms to testosterone gel or placebo gel for one year, each man taking part in one or more of three trials [10]. Testosterone rose to the mid-normal range for men aged 19 to 40. Sexual activity on the Psychosexual Daily Questionnaire increased (P<0.001), as did sexual desire and erectile function. In the Physical Function Trial, the share of men who added at least 50 m to the 6-minute walk did not differ significantly between groups; across all three trials it did (20.5% vs 12.6%, P=0.003). There was no benefit on the vitality scale, and mood and depressive symptoms improved slightly on testosterone. Adverse event rates were similar, and the trial was too small to draw conclusions about risks [10].

Bone density was tested in 211 of these men over 12 months. Spine trabecular volumetric bone mineral density rose 7.5% on testosterone against 0.8% on placebo, a treatment effect of 6.8% (P<.001), with corresponding gains in estimated bone strength [11].

A pharmacokinetic study of 227 hypogonadal men given a 1% hydroalcoholic testosterone gel at 50 or 100 mg a day, or a testosterone patch, found that the gel dried within a few minutes and that about 9 to 14% of the applied testosterone was bioavailable. Serum testosterone rose into the normal adult male range on day 1, the authors cite their earlier study showing steady state 48 to 72 hours after the first application, and mean levels stayed stable across 180 days of daily use, with dose titration at 90 days if pre-application levels fell outside the normal range [12].

Cardiovascular safety: TRAVERSE

TRAVERSE was a randomized, double-blind, placebo-controlled noninferiority trial, and FDA describes it as an FDA-required postmarketing safety trial [1][2]. It enrolled 5,246 men aged 45 to 80 with symptoms of hypogonadism, two fasting testosterone levels below 300 ng/dL, and existing cardiovascular disease or high cardiovascular risk, assigned to daily 1.62% testosterone gel or placebo gel. Mean treatment was 21.7 months and mean follow-up 33.0 months [2].

A first major cardiovascular event, meaning 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), which met the prespecified noninferiority margin [2]. Atrial fibrillation, acute kidney injury and pulmonary embolism occurred more often with testosterone [2]. The result comes from one gel in a population selected for cardiovascular risk; FDA's own labeling action states that ambulatory monitoring confirmed blood pressure increases with all testosterone products [6].

Monitoring during treatment

The Endocrine Society recommends evaluating symptoms, adverse effects and adherence in the first year of treatment, measuring serum testosterone and hematocrit, and assessing prostate cancer risk [4]. The AUA describes rechecking testosterone every 6 to 12 months on therapy [5].

Across 29 placebo-controlled randomized trials in 3,393 men, every testosterone formulation raised mean hematocrit versus placebo: gel by 3.0% (95% CI 1.8 to 4.3), intramuscular enanthate or cypionate by 4.0% (95% CI 2.9 to 5.1), oral testosterone undecanoate by 4.3%, patch by 1.4% and intramuscular testosterone undecanoate by 1.6%; enanthate or cypionate rose significantly more than patch [13].

Fertility

Testosterone therapy suppresses sperm production. The Endocrine Society recommends against starting testosterone in men planning fertility in the near term [4], and the AUA position is that exogenous testosterone should not be prescribed to men currently trying to conceive [5].

Recovery after stopping is common but variable. In a retrospective series of 66 men with infertility after testosterone use who stopped testosterone and received high-dose hCG plus a selective estrogen receptor modulator, 46 (70%) reached a total motile count above 5 million within 12 months; 64.8% of azoospermic men did, against 91.7% of cryptozoospermic men, and older age and longer testosterone use predicted slower recovery [14].

Who the guidelines say should not start

The Endocrine Society recommends against starting testosterone in men with breast cancer or prostate cancer, a palpable prostate nodule or induration, PSA above 4 ng/mL or above 3 ng/mL in men at increased prostate cancer risk without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the past 6 months, or thrombophilia, and in men planning fertility in the near term. These are guideline recommendations rather than an FDA contraindication list [4].

The same guideline suggests against routinely prescribing testosterone to every man aged 65 or older with low testosterone, favoring an individual discussion for symptomatic men with consistently low morning levels [4]. For age-related low testosterone, the American College of Physicians suggests considering intramuscular rather than transdermal formulations on cost grounds with similar effectiveness and harms, reevaluating within 12 months and stopping if sexual function does not improve, and not starting testosterone to improve energy, vitality, physical function or cognition [15].