AndroGel Monitoring Schedule: Labs, Exams, and Follow-Up Timeline

Before the first dose

Before treatment, the testosterone gel 1% label calls for morning serum testosterone measured on at least two separate days, with both results below the normal range [1]. The label also calls for hematocrit before treatment begins and evaluation for prostate cancer before and during treatment, and it says the gel is not recommended in men with uncontrolled hypertension [1].

The starting dose is 50 mg once daily in the morning, applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen — not the genitals, chest, armpits, knees or back [1]. The dose can be adjusted to 75 or 100 mg based on serum testosterone [1].

Hematocrit: before, 3 to 6 months, then yearly

Hematocrit is the one lab the label places on a defined schedule: before treatment, again 3 to 6 months after starting, and then annually [1]. The label says that if hematocrit becomes elevated, stop therapy until it decreases to an acceptable concentration, and notes that an increase in red blood cell mass may raise the risk of thromboembolic events [1]. That section gives no numeric cutoff [1].

How big a rise to expect depends partly on the formulation. A network meta-analysis of 29 placebo-controlled randomized trials (3,393 men) found mean hematocrit rose 3.0% with gel (95% CI 1.8 to 4.3) and 4.0% with intramuscular enanthate or cypionate (95% CI 2.9 to 5.1), each versus placebo [4]. A retrospective review of 178 hypogonadal men followed for 3 years found hematocrit above 50% in 12.8% of men on gels, 66.7% on injectable testosterone and 35.1% on pellets; the injectable group was younger and started with a higher hematocrit, and the study was not randomized [5]. Another review reported a 315% greater risk of erythrocytosis (hematocrit above 0.52) with testosterone therapy than in controls, with short-acting injectables highest [6].

Serum testosterone: the number that drives dose changes

Serum testosterone is checked periodically during treatment [1], and the guideline recommends it as part of first-year monitoring along with symptoms, hematocrit and prostate cancer risk [2].

In TRAVERSE, the daily 1.62% gel dose was adjusted to keep testosterone between 350 and 750 ng/dL [3]; that was a trial protocol for the 1.62% gel, not a dosing instruction for the 1% gel. In the Testosterone Trials, 790 men aged 65 or older with testosterone below 275 ng/dL used gel for a year, and treatment raised levels into the mid-normal range for men aged 19 to 40 [7].

PSA and prostate follow-up

The label says to evaluate patients for prostate cancer before starting and during treatment, to monitor men with benign prostatic hyperplasia for worsening symptoms, and to check PSA periodically [1].

The label's own trial data show what follow-up can turn up. In the initial 180-day study, mean PSA rose 0.26 ng/mL, a statistically significant change [1]. PSA was then measured every 6 months in 162 men in a 3-year extension study: the group mean did not rise significantly further, with an overall mean change from month 6 to month 36 of 0.11 ng/mL, but about 18% of individual men had a rise, and 29 men (18%) met the protocol criterion of more than twice baseline or any single PSA above 6 ng/mL [1]. In 23 of those 29 men the first such value came at or before month 12 [1]. Four men had a PSA above 6 ng/mL, and prostate cancer was found on biopsy in two of them [1].

Blood pressure and cardiovascular follow-up

The 1% gel label carries ambulatory blood pressure data. In a 4-month study, 246 patients were monitored; 169 had usable recordings at both baseline and week 16 and at least 85% adherence, and in that group mean 24-hour systolic and diastolic pressure rose 1.9 mm Hg (95% CI 0.6 to 3.1) and 1.3 mm Hg (95% CI 0.5 to 2.1) [1]. In men with hypertension already on blood pressure medicine, 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 uncontrolled hypertension [1].

TRAVERSE enrolled 5,246 men aged 45 to 80 with existing cardiovascular disease or high risk and randomized them to daily 1.62% testosterone gel or placebo gel, with mean treatment of 21.7 months and mean follow-up of 33 months [3]. The primary endpoint — cardiovascular death, nonfatal heart attack or nonfatal stroke — occurred in 7.0% (182 men) on testosterone and 7.3% (190 men) on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority [3]. Mean systolic pressure rose 1.0 mm Hg with gel against a 0.5 mm Hg fall with placebo at 36 months [1]. The gel label reports venous thromboembolism in 1.7% of the testosterone group versus 1.2% of placebo, including deep vein thrombosis in 0.6% versus 0.5% and pulmonary embolism in 0.9% versus 0.5% [1]; it says to stop the gel and evaluate if a venous thromboembolic event is suspected [1].

In February 2025 FDA recommended adding TRAVERSE results to testosterone product labels, removing boxed-warning language about increased cardiovascular risk, and adding a blood pressure warning where one was missing; ambulatory monitoring had confirmed a blood pressure increase across all testosterone products [8]. In June 2026 FDA asked sponsors for further changes, including removing the limitation of use for age-related hypogonadism and revising prostate cancer and BPH safety information; that is a request, and not every label reflects it yet [9].

Secondary exposure: the household check

The gel label carries a boxed warning for secondary exposure [1]. Reported signs in children include enlargement of the penis or clitoris, pubic hair, more erections and libido, aggressive behavior and advanced bone age; in most cases these regressed once exposure stopped, but in a few, genital enlargement did not fully return to age-appropriate size and bone age stayed modestly advanced [1]. The label says children and women should avoid contact with unwashed or unclothed application sites, and that the gel should be promptly discontinued until the cause of virilization is identified [1]. The gel is flammable until dry [1].

Other labs, and interactions that change monitoring

Liver function tests and lipids are on the label's list of labs to check periodically [1]. Acne, application site reaction, abnormal lab tests and prostatic disorders are the adverse reactions reported in 5% or more of patients [1].

The label lists three interactions:

• Oral anticoagulants: androgens can change anticoagulant activity, and the label recommends more frequent INR and prothrombin time checks, especially when testosterone is started or stopped [1].
• Insulin and diabetes medicines: androgens may lower blood glucose and reduce insulin requirements [1].
• Corticosteroids or ACTH: combined use may increase fluid retention and needs careful monitoring, particularly with heart, kidney or liver disease [1].

Year-one timeline at a glance