Testosterone Reference

Reference summary

Endocrine Society 2018 clinical practice guideline (Bhasin 2018 JCEM) is the bedrock prescribing reference: biochemical confirmation, target trough to mid-normal range, lab monitoring schedule (hematocrit, PSA, lipids), and contraindications (untreated obstructive sleep apnea, hematocrit >54 percent, breast or prostate cancer, recent MI, severe heart failure). TRAVERSE (Lincoff 2023 NEJM, n=5,246) was the FDA-mandated post-marketing cardiovascular safety trial; it reported non-inferiority of testosterone vs placebo for the primary MACE composite over a mean 21.7 months in men with hypogonadism and pre-existing or high cardiovascular risk, but did report higher rates of pulmonary embolism, atrial fibrillation, and acute kidney injury in the testosterone arm.

Regulatory and posture

Categories

Hormonal, Reproductive

Aliases

Testosterone cypionate (Depo-Testosterone), Testosterone enanthate (Xyosted), Testosterone propionate, Testosterone undecanoate (Aveed, Jatenzo), Schedule III controlled substance, Anabolic-androgenic steroid (small molecule, not a peptide)

Evidence posture

human - TRAVERSE showed cardiovascular non-inferiority but higher PE / AF / AKI in the testosterone arm. Erythrocytosis monitoring is mandatory.

Regulatory status

FDA-approved Schedule III controlled substance for testosterone replacement therapy (TRT) in men with primary or hypogonadotropic hypogonadism, with biochemical confirmation (typically two morning total testosterone measurements below the local lab reference range plus clinical signs). Multiple esters and routes are approved: cypionate and enanthate for IM injection, propionate (less commonly used today), undecanoate IM (Aveed) or oral (Jatenzo), transdermal gels (AndroGel, Testim), and patches. Compounded subcutaneous testosterone is an off-label preparation that some prescribers use; the dose is not FDA-validated at the protocol level. WADA-prohibited at all times under S1.

Content review status

label verified