AndroGel Geriatric Dosing: Testosterone Gel Guidelines for Men 65 and Older

Is there a different dose of testosterone gel 1% for men 65 and older?

No. The testosterone gel 1% label gives one dosing schedule for adults, and its geriatric-use section does not give a separate dose for older men [1]. The dose is adjusted for each man by his serum total testosterone.

What the label does address is evidence. Its geriatric section states that there have not been sufficient numbers of geriatric patients in controlled clinical studies of testosterone gel 1% to determine whether efficacy in those over 65 differs from younger subjects, and that there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer [1]. The same section notes that geriatric patients treated with androgens may also be at risk for worsening signs and symptoms of benign prostatic hyperplasia (BPH) [1].

The label's limitation of use is worth knowing for this age group: safety and efficacy of testosterone gel 1% in men with age-related hypogonadism (late-onset hypogonadism) have not been established [1]. FDA has asked manufacturers to remove that limitation and to revise the prostate cancer and BPH safety information [3]; the 1% gel label (effective September 2025) still carries the old text, so the change has been requested, not made [1]. FDA also states that none of the approved testosterone products are approved for men with low testosterone who lack an associated medical condition [3].

What the label says about starting and adjusting the dose

The starting dose of testosterone gel 1% is 50 mg of testosterone once daily in the morning, delivered as four pump actuations, two 25 mg packets, or one 50 mg packet [1]. Before the first dose, the label requires confirmation of hypogonadism by morning serum testosterone measurements on at least two separate days, both below the normal range [1].

The dose is then adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration [1]. The testosterone gel 1% label specifies clean, dry, intact skin on the shoulders, upper arms or abdomen as application sites, and says not to apply to other parts of the body including the genitals, chest, armpits, knees, or back [1]. The label notes the gel is flammable until dry [1].

The 1% and 1.62% gels are not the same product

A 1% gel and a 1.62% gel do not share a dose. The label says plainly that dosage and administration for testosterone gel 1% differs from testosterone gel 1.62%, and directs readers to the full prescribing information for the 1.62% product [1]. It also warns that topical testosterone products may have different doses, strengths or application instructions, which can produce different systemic exposure [1].

For the 1.62% gel, the 1% label sends readers to that product's own prescribing information [1].

Blood pressure in men over 65

FDA reviewed required ambulatory blood pressure monitoring studies after concerns were raised about testosterone and blood pressure, and the completed studies confirmed a blood pressure increase with all testosterone products, class-wide [2]. As part of its February 2025 labeling action, FDA required a blood pressure warning in products that lacked one and product-specific blood pressure data where monitoring studies existed, and removed boxed-warning language about increased cardiovascular risk [2].

For testosterone gel 1%, the label states that the drug can increase blood pressure and that blood pressure increases can raise cardiovascular risk over time, that blood pressure should be measured periodically, and that the product is not recommended for men with uncontrolled hypertension [1]. In a 4-month ambulatory monitoring study, mean 24-hour systolic/diastolic blood pressure rose 1.9/1.3 mm Hg from baseline to week 16 in 169 patients with usable recordings; in patients with hypertension already on antihypertensive therapy, the rise was 3.0/2.2 mm Hg [1].

In the TRAVERSE cardiovascular outcomes trial, which enrolled 5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk, mean systolic blood pressure on testosterone gel rose 1.0 mm Hg to 36 months against a 0.5 mm Hg fall on placebo [4][1]. Major adverse cardiovascular events occurred in 7.0% on testosterone gel versus 7.3% on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority [4].

Hematocrit, PSA and clotting risk

The label directs a hematocrit check before starting, re-evaluation at 3 to 6 months, and then annual checks; if hematocrit becomes elevated, therapy is stopped until it falls to an acceptable concentration, and the label notes that an increase in red blood cell mass may raise thromboembolic risk [1]. Periodic monitoring of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids is also recommended [1].

On the prostate, the label states that patients with BPH treated with androgens are at increased risk of worsening signs and symptoms, and that patients treated with androgens may be at increased risk for prostate cancer, so evaluation for prostate cancer is advised before and during treatment [1]. Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, has been reported with testosterone products [1]. TRAVERSE's publication describes a 1.62% testosterone gel [4]; the 1% label also reports the trial's results [1].

Two gaps are stated in the label itself: no studies were conducted in patients with renal impairment, and none in patients with hepatic impairment [1].

What one year of testosterone gel did in men 65 and older

The clearest trial evidence in this age group comes from a randomized, placebo-controlled study of 790 men aged 65 or older with symptoms suggesting low testosterone and a serum testosterone below 275 ng/dL, treated with testosterone gel or placebo gel for one year [5]. Participants were enrolled across three component trials covering sexual function, physical function and vitality, and the primary outcome of each was also assessed in all participants [5].

Testosterone raised serum levels into the mid-normal range for men aged 19 to 40 and significantly increased sexual activity, sexual desire and erectile function [5]. In the physical function trial the share of men gaining at least 50 m in six-minute walk distance did not differ significantly between groups, but across all three trials it did: 20.5% on testosterone versus 12.6% on placebo (P=0.003) [5]. There was no significant benefit on the vitality scale, mood and depressive symptoms improved slightly, and adverse event rates were similar between groups [5]. The investigators cautioned that the number of participants was too small to draw conclusions about the risks of treatment [5].

A bone-density study within the same program included 211 men with a mean age of 72.3 years who received testosterone gel or placebo gel for one year, with spine and hip bone density measured by quantitative CT [6]. Spine trabecular volumetric bone density rose 7.5% on testosterone versus 0.8% on placebo, and estimated strength of spine trabecular bone rose 10.8% versus 2.4% [6].

Medicines that interact with testosterone gel

The label lists three interaction areas [1]. Androgens may decrease blood glucose and therefore decrease insulin requirements in diabetic patients [1]. Changes in anticoagulant activity may occur with androgens, so more frequent monitoring of INR and prothrombin time is recommended, especially at the start and at the end of androgen therapy [1]. Use with ACTH or corticosteroids may increase fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease [1].

When the Endocrine Society advises against starting

The 2018 Endocrine Society guideline recommends against starting testosterone therapy in men planning fertility in the near term, and in men with breast or prostate cancer, elevated hematocrit, untreated severe sleep apnea, uncontrolled heart failure, or a heart attack or stroke within the previous 6 months [7]. It also recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year [7].

Secondary exposure at home

The boxed warning on testosterone gel 1% concerns secondary exposure, not cardiovascular risk: 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 regressed when exposure was removed, though in a few, enlarged genitalia did not fully return to age-appropriate size [1]. The label directs that the gel be discontinued until the cause of virilization is identified [1]. The gel is also contraindicated in women who are pregnant because it can cause virilization of the female fetus [1].