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  5. Testosterone Information
  1. Postmarket Drug Safety Information for Patients and Providers

Testosterone Information

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.

None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.

An industry consortium, led by manufacturers of AndroGel and Androderm, conducted an FDA-required postmarketing safety trial titled the Testosterone Replacement Therapy for Assessment of Longterm Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) trial (using AndroGel 1.62%) to assess cardiovascular outcomes. The primary endpoint was the first occurrence of a composite of death from cardiovascular causes, nonfatal myocardial infarction (MI), and nonfatal stroke, assessed in a time to event analysis. Noninferiority required an upper limit of 1.5 for the 95% confidence interval of the hazard ratio among patients receiving at least one dose. TRAVERSE demonstrated non-inferiority of AndroGel 1.62% vs. placebo by excluding a hazard ratio >1.5 (HR, 0.96; 95% CI, 0.78 to 1.17). The incidence of major adverse cardiovascular event (MACE) for subjects receiving AndroGel was 7.0%; for those receiving placebo it was 7.3%. After Agency review, it was determined that the results of TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes with testosterone use.

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