Review of Testim® gel

Abstract

Hypogonadism is a medical condition characterised by testosterone deficiency in males, accompanied by numerous clinical symptoms, which can negatively affect quality of life and multiple organ systems. Late-onset hypogonadism describes testosterone deficiency or reduced effect seen in ageing men. The conditions are generally managed using testosterone supplementation. Many formulations of testosterone are available, including deep-muscle injections, buccal formulations, transdermal patches and topical gels. Testim® gel 1% testosterone gel (Auxilium Pharmaceuticals, Inc. and Ipsen) has been shown to restore serum testosterone concentrations to within the normal range in men with hypogonadism. Two randomised, controlled studies showed that Testim gel significantly improved sexual motivation, desire, performance and function, as well as positive and negative mood scores and body composition after 90 days, compared with baseline. The magnitude of improvement seen with Testim gel was similar to that achieved with testosterone patches, but with fewer application-site reactions. In another study, improvements in mood and sexual function were seen within the first 2 weeks of treatment. Long-term, open-label extension studies of Testim gel suggest that clinical benefits are maintained for ≤ 12 months without an additional increase in side effects. Notably, Testim gel treatment for 12 months was associated with a gradual increase in bone mineral density, suggesting that Testim gel may help to prevent osteoporosis. The most common adverse events associated with Testim gel were application-site reactions, increased haematological parameters, and moderately increased prostate-specific antigen levels that remained within the normal range in 96% of subjects. Men on any testosterone therapy will require careful monitoring, including serial digital rectal examination and prostate-specific antigen testing. Overall, the clinical evidence so far indicates that Testim gel is a safe and effective treatment option for daily use in the management of male hypogonadism.