AndroGel Monitoring for Older Adults (Ages 50 to 64): A Clinical Guide

What monitoring covers

The testosterone gel 1.62% label lists the parameters to follow: serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipid concentrations, all checked periodically, plus blood pressure measured periodically, especially in men with hypertension [1]. Hematocrit is the one with its own clock — before starting, again 3 to 6 months in, then annually [1].

The label also notes that long-term safety data in geriatric patients using the 1.62% gel are insufficient to assess cardiovascular and prostate cancer risk [1].

Does the diagnosis fit an approved use?

FDA-approved testosterone products are for men who lack or have low testosterone along with an associated medical condition — testicular failure, or a problem in the hypothalamus or pituitary [2]. None is approved for low testosterone without such a condition [2]. The 1.62% gel label carries the same limit: safety and efficacy in age-related hypogonadism have not been established [1].

FDA kept that limitation in its February 2025 class-wide label changes and asked for its removal in June 2026, along with revisions to prostate cancer and benign prostatic hyperplasia safety information [4][2]. The label text still carries the limitation, so the accurate phrasing is that FDA has asked for the change [1][2].

Diagnosis means morning serum testosterone measured on at least two separate days, both below the normal range [1]. Timing matters: among 66 men aged 30 to 80, testosterone was 20 to 25% lower at 4 p.m. than at 8 a.m. in the youngest men, and about 10% lower in men around 70 [5].

Hematocrit

In a network meta-analysis of 29 placebo-controlled randomized trials covering 3,393 men, mean hematocrit rose 3.0% with gel (95% CI 1.8 to 4.3) and 4.0% with intramuscular enanthate or cypionate (2.9 to 5.1), both compared with placebo; the gel and intramuscular figures were not significantly different from each other [3].

In a dose-response study, 60 men aged 60 to 75 and 61 men aged 19 to 35 received weekly testosterone enanthate injections for 20 weeks; hemoglobin and hematocrit rose in a linear, dose-dependent way in both groups, and the rises were significantly greater in the older men [6]. That study used injections, not gel.

The label's instruction: if hematocrit becomes elevated, stop therapy until it falls to an acceptable concentration; an increase in red blood cell mass may raise the risk of thromboembolic events [1].

Blood pressure

The gel can increase blood pressure, which can raise cardiovascular risk over time, and the label says to measure it periodically, especially in men with hypertension; it is not recommended for men with uncontrolled hypertension [1].

Ambulatory monitoring gives the size of the effect. In 169 patients with usable recordings, 24-hour systolic and diastolic pressure rose a mean of 1.9 and 1.3 mm Hg from baseline to week 16 [1]. In 72 men already on antihypertensive treatment the rise was 3.0 and 2.2 mm Hg; in 91 men without a hypertension history, 1.2 and 0.9 mm Hg [1]. Four patients (2.8%), all on antihypertensives at baseline, started a new blood pressure medicine or had their regimen adjusted during that study [1].

In TRAVERSE, mean systolic blood pressure rose 1.0 mm Hg with gel and fell 0.5 mm Hg with placebo at 36 months, a between-group difference of 1.5 mm Hg [1].

PSA and prostate

Known or suspected prostate cancer is a contraindication to the 1.62% gel [1]. The label asks that men with benign prostatic hyperplasia be monitored for worsening symptoms, and states that patients treated with androgens may be at increased risk for prostate cancer, with evaluation before and during treatment [1].

In the 182-day double-blind trial (234 men on gel, 40 on placebo), increased PSA was the most common adverse reaction, 11.1% versus 0% [1]. The trial counted a PSA as abnormal if the average of two determinations was above 4 ng/mL, or the average change from baseline was greater than 0.75 ng/mL on two determinations [1]. Mean PSA change over that period was 0.14 ng/mL on gel and -0.12 ng/mL on placebo [1]. FDA's June 2026 request included revised prostate cancer and BPH safety information [2].

The medication list at each visit

The label names three interaction areas [1]:

• Oral anticoagulants. Anticoagulant activity can change, and more frequent INR and prothrombin time monitoring is recommended, especially when testosterone is started or stopped [1].
• Insulin and diabetes medicines. Androgens may lower blood glucose and therefore decrease insulin requirements [1].
• Corticosteroids or ACTH. Taken with testosterone, they may increase fluid retention, which calls for careful monitoring, particularly with cardiac, renal or hepatic disease [1].

Glucocorticoids have also been linked to lower serum testosterone. In a 1986 study of 16 men with chronic pulmonary disease (mean age 67), testosterone was reduced in 14 of them, to a mean of 211 ng/dL versus 449 ng/dL in 11 matched controls [7]. That study did not test men using testosterone gel [7].

Secondary exposure: the boxed warning

The boxed warning on the 1.62% gel is not about the heart. It is about other people: virilization has been reported in children secondarily exposed to testosterone gel, children should avoid contact with unwashed or unclothed application sites, and patients should follow the instructions for use closely [1].

Reported signs include enlargement of the penis or clitoris, pubic hair development, increased erections and libido, aggressive behavior and advanced bone age; in most cases these regressed when exposure was removed, but in a few, enlarged genitalia did not fully return to age-appropriate size and bone age stayed modestly greater than chronological age [1]. Secondary exposure with virilization should prompt discontinuation of the gel until the cause is identified, per the label [1].

Application for the 1.62% gel is to clean, dry, intact skin of the shoulders and upper arms only — not the abdomen, genitals, chest, armpits or knees — and the gel is flammable until dry [1].

What the trials settle and what they do not

TRAVERSE randomized 5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk to daily 1.62% testosterone gel or placebo gel [8]. A major adverse cardiovascular event occurred in 7.0% on testosterone versus 7.3% on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority [8]. Venous thromboembolism was 1.7% versus 1.2% [1]; atrial fibrillation 3.5% versus 2.4% and nonfatal arrhythmias requiring intervention 5.2% versus 3.3% [8].

FDA's sequence here has two steps. A March 2015 drug safety communication required labeling changes and urged caution with testosterone for low testosterone due to aging; the February 2025 class-wide action removed boxed-warning language about adverse cardiovascular outcomes and added the blood pressure warning [4].