AndroGel Geriatric (65+) Monitoring: Lab Tests, Safety Checks, and Dose Adjustments

What the testosterone gel 1% label says about men over 65

The label's geriatric section says too few men over 65 took part in controlled studies of this gel to determine whether efficacy differs by age, and that long-term safety data are insufficient to assess cardiovascular disease and prostate cancer risk in that group. It adds that older men treated with androgens may be at risk for worsening signs and symptoms of benign prostatic hyperplasia [1].

The label also notes that topical testosterone products may have different doses, strengths or application instructions that produce different systemic exposure, and that the 1.62% gel has its own prescribing information [1].

The same label also carries a limitation of use: safety and efficacy in men with age-related hypogonadism, also called late-onset hypogonadism, have not been established [1]. FDA has asked manufacturers to remove that limitation and to revise prostate cancer and BPH safety information, a request the agency described in June 2026 [2]. The 1% gel label (effective September 2025) still carries the old limitation text, so the removal is a requested change, not a completed one [1][2].

FDA's position on who the drug is for has not otherwise shifted: testosterone products are approved only for men who have low testosterone along with an associated medical condition such as testicular failure or a pituitary or hypothalamic problem, not for low testosterone without one [2].

Which labs the testosterone gel 1% label asks for, and how often

The warnings section lists the tests to follow during treatment: serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipid concentrations, checked periodically [1]. Only hematocrit comes with a stated schedule. The testosterone gel 1% label says to check it before starting, re-evaluate it 3 to 6 months after starting, and then annually. If it becomes elevated, the label says to stop therapy until hematocrit falls to an acceptable concentration, and notes that an increase in red blood cell mass may raise the risk of thromboembolic events [1]. No numeric stop threshold appears in that instruction.

The size of the hematocrit rise depends partly on the formulation. A 2022 network meta-analysis of 29 placebo-controlled trials (3,393 men) found mean hematocrit 3.0% higher with gel than placebo (95% CI 1.8 to 4.3) and 4.0% higher with intramuscular enanthate or cypionate (95% CI 2.9 to 5.1) [3]. A 2015 review reported a 315% greater risk of erythrocytosis, defined there as hematocrit above 0.52, in men on testosterone compared with controls [4].

PSA has its own data set. In the 180-day phase 3 trial of the 1% gel, mean PSA rose by 0.26 ng/mL, a statistically significant change; across the 3-year extension the group mean did not climb further, but 29 of 162 men (18%) met a protocol criterion of more than twice baseline or any single value above 6 ng/mL, and 23 of those 29 first met it by month 12 [1]. The label asks that men with BPH be watched for worsening symptoms and that all men be evaluated for prostate cancer before and during treatment [1]. The Endocrine Society's 2018 guideline recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk through the first year [5].

For lipids, a 2010 meta-analysis of 51 studies found testosterone lowered HDL cholesterol by 0.49 mg/dL (95% CI -0.85 to -0.13) and raised hematocrit by 3.18% [6].

Blood pressure and cardiovascular checks

Blood pressure is the monitoring item with the clearest measured effect. In a 4-month ambulatory blood pressure study of the 1% gel, mean 24-hour systolic/diastolic pressure rose 1.9/1.3 mm Hg from baseline at week 16 in 169 men with usable recordings, and in men with a history of hypertension already on antihypertensive treatment the rise was 3.0/2.2 mm Hg [1]. The label says to measure blood pressure periodically, especially in men with hypertension, and that the gel is not recommended for men with uncontrolled hypertension [1].

TRAVERSE used a daily 1.62% testosterone gel [7]. It randomized 5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk to 1.62% gel or placebo gel, with the dose adjusted to keep testosterone between 350 and 750 ng/dL. Major adverse cardiovascular events occurred in 7.0% on testosterone versus 7.3% on placebo (hazard ratio 0.96, 95% CI 0.78 to 1.17), meeting noninferiority over a mean follow-up of 33 months and a mean treatment period of 21.7 months [7]. The 1% gel label also reports the trial's results, including a mean systolic pressure rise of 1.0 mm Hg on gel versus a 0.5 mm Hg fall on placebo at 36 months, and venous thromboembolism in 1.7% versus 1.2%, including pulmonary embolism 0.9% versus 0.5% and deep vein thrombosis 0.6% versus 0.5% [1]. The label says to evaluate leg pain, swelling, warmth or erythema for DVT and acute shortness of breath for PE, and to discontinue if a venous thromboembolic event is suspected [1].

One substudy of the Testosterone Trials looked at coronary plaque in 170 men aged 65 or older, of whom 138 had usable scans. Noncalcified plaque volume rose more with testosterone than with placebo, an estimated difference of 41 mm3 (95% CI 14 to 67; P=.003) [8].

Dose adjustments in older men

The 1% gel starts at 50 mg of testosterone once daily in the morning, applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen, and is adjusted to 50, 75 or 100 mg based on total serum testosterone [1]. The label's geriatric-use section gives no age-specific dose [1]. Before the first application, the label says the diagnosis is confirmed with morning serum testosterone measured on at least two separate days, both below the normal range [1]. The label also directs the gel away from the genitals, chest, armpits, knees and back [1].

Safety checks beyond the lab sheet

Testosterone gel 1% carries a boxed warning about secondary exposure. Virilization has been reported in children exposed to treated skin, and the label says children and women should avoid unwashed or unclothed application sites [1]. That label also warns that edema, with or without heart failure, may occur in men with preexisting cardiac, renal or hepatic disease, and that sleep apnea may occur in men with risk factors [1]. The Endocrine Society recommends against starting testosterone in men with untreated severe sleep apnea, uncontrolled heart failure, or a heart attack or stroke within the previous 6 months [5].

Interactions listed in the label

Three interactions are spelled out in the gel label. Changes in anticoagulant activity may occur with androgens, so the label recommends checking INR and prothrombin time more often, particularly when starting or stopping the gel [1]. Androgens may lower blood glucose and therefore reduce insulin requirements [1]. Combined with corticosteroids or ACTH, fluid retention may increase, particularly in men with cardiac, renal or hepatic disease [1].

What is not established in this age group

The label states that no studies were conducted in patients with renal impairment and none in patients with hepatic impairment [1].

Bone has one randomized trial in older men. In a 1-year substudy of 211 men aged 65 and older, spine trabecular volumetric bone density rose 7.5% with testosterone versus 0.8% with placebo, a treatment effect of 6.8% (95% CI 4.8% to 8.7%; P<.001) [9]. That trial measured density and estimated bone strength, not fractures.

Function was modest in the main Testosterone Trials, which gave gel or placebo for 1 year to 790 men aged 65 and older with testosterone below 275 ng/dL. When all three trials were pooled, 20.5% of men on testosterone versus 12.6% on placebo improved six-minute walking distance by at least 50 m, and there was no benefit on vitality scores [10].