Testosterone Cypionate

Status

FDA-approved. FDA-approved labeling exists for testosterone replacement in males with conditions associated with a deficiency of endogenous testosterone, specifically primary hypogonadism and hypogonadotropic hypogonadism. Labels state it is not approved for age-related low testosterone. Testosterone is a Schedule III controlled substance, and labeling carries warnings on blood pressure increases, erythrocytosis, venous thromboembolism and abuse potential.

What it is

A long-acting injectable testosterone ester common in prescribed therapy.

What published research measured

A long-acting injectable testosterone ester and the most commonly prescribed form in the United States. Randomized evidence in men with diagnosed hypogonadism is substantial: the Testosterone Trials in older men reported improvements in sexual function, mood and bone density, with less convincing effects on vitality and cognition. The cardiovascular question that shadowed this drug for a decade was addressed by the TRAVERSE trial published in 2023, which randomized over five thousand middle-aged and older men with hypogonadism and cardiovascular risk and found testosterone non-inferior to placebo for major adverse cardiac events — while reporting higher rates of atrial fibrillation, acute kidney injury and pulmonary embolism. Suppression of spermatogenesis is expected and can be prolonged. Erythrocytosis is the most common laboratory abnormality requiring intervention.

Source

TRAVERSE cardiovascular safety trial, New England Journal of Medicine 2023 · The Testosterone Trials (T-Trials) · FDA labeling for testosterone injection

Sources

• Testosterone cypionate label (DailyMed)