AndroGel Compounded vs Branded: A Clinical Comparison

What actually differs between AndroGel and a compounded gel?

AndroGel 1.62% is the gel that the TRAVERSE trial tested [1]. A compounded testosterone gel is not FDA-approved, and FDA does not review compounded drugs to evaluate their safety, effectiveness or quality before they reach patients [2]. Federal compounding rules differ by facility. Compounders working under the prescription-based pathway must compound against valid patient-specific prescriptions. A separate, voluntary category of outsourcing facilities is subject to current good manufacturing practice requirements, is inspected by FDA on a risk-based schedule, and may distribute compounded drugs either under a patient-specific prescription or in response to an order from a health care provider that is not for an identified individual patient [2].

Do topical testosterone gels differ in dosing and exposure?

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, that its dosage and administration differ from testosterone gel 1.62%, and that the application site and dose of testosterone gel 1% are not substitutable with other topical testosterone products [3]. AndroGel 1.62% is the gel used in TRAVERSE [1].

Blood pressure and cardiovascular risk

In February 2025, FDA announced class-wide labeling changes for testosterone products: adding the TRAVERSE results to labeling, keeping the limitation of use for age-related hypogonadism, removing boxed-warning language about an increased risk of adverse cardiovascular outcomes, and adding a blood pressure warning to products that lacked one. FDA said ambulatory monitoring studies confirmed a blood pressure increase with all testosterone products, class-wide [7].

TRAVERSE randomized 5,246 men aged 45 to 80 with hypogonadism and existing or high risk of cardiovascular disease to daily 1.62% testosterone gel or placebo gel, with mean treatment of 21.7 months. A primary cardiovascular event occurred in 7.0% of the testosterone group and 7.3% of the placebo group, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority [4].

Hematocrit and red blood cells

Across 29 placebo-controlled randomized trials of testosterone formulations covering 3,393 men, gel was associated with a mean hematocrit increase of 3.0% versus placebo (95% CI 1.8 to 4.3), and intramuscular enanthate or cypionate with 4.0% (95% CI 2.9 to 5.1) [5].

The risk of erythrocytosis with testosterone therapy is well established, and short-acting injectable formulations have the highest incidence [8]. One review found men on testosterone replacement had a 315% greater risk of erythrocytosis, defined as a hematocrit above 0.52, than controls [9].

Is compounded testosterone gel as effective as AndroGel?

The trials cited on this page tested an approved gel against placebo, so they do not show how a compounded gel compares with AndroGel on serum testosterone, symptoms or adverse events [4]. The Endocrine Society guideline says to diagnose hypogonadism only in men with symptoms and consistently low testosterone, using a morning fasting total testosterone as the first test and repeating it to confirm, and it recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year of therapy [10].

What applies to testosterone either way

Testosterone is a Schedule III controlled substance under the Controlled Substances Act [6].

The Endocrine Society 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 6 months [10].