Testosterone Gel

Status

FDA-approved. FDA-approved labeling exists for several transdermal gel products for testosterone replacement in males with primary or hypogonadotropic hypogonadism. All carry a boxed warning for secondary exposure causing virilization in children. Schedule III controlled substance.

What it is

A daily transdermal testosterone preparation used in prescribed therapy.

What published research measured

Transdermal testosterone delivered daily, producing serum concentrations that track a more physiological daily rhythm than intermittent injections. Randomized trials support efficacy in hypogonadism, and it was the delivery form used in several of the Testosterone Trials. Its defining risk is not pharmacological but practical: secondary exposure through skin contact. Documented cases of virilization in children and in female partners after contact with treated skin led to a boxed warning, and the mitigation — covering the application site, washing hands, avoiding contact until absorbed — is part of the approved labeling rather than optional advice. Application site skin reactions are common, and absorption varies more between individuals than injected esters do.

Source

FDA labeling for transdermal testosterone gels, including the secondary exposure boxed warning

Sources

• Testosterone cypionate label (DailyMed)