Testim ® Gel: Review of Clinical Data

Abstract

Late-onset hypogonadism is a medical condition characterized by testosterone deficiency in ageing men, accompanied by clinical symptoms, that can negatively affect quality of life and multiple organ systems. The condition is generally managed using testosterone substitution. Many formulations of testosterone are available, including deep-muscle injections, buccal formulations, transdermal patches, and topical gels. Testim ® Gel 1% testosterone gel (Auxilium Pharmaceuticals – Norristown, Pennsylvania, USA, and Ipsen – Paris, France) has been shown to restore serum testosterone concentrations to within the normal range in men with hypogonadism. Two randomized, 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. 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 up to 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. Overall, the clinical evidence indicates that Testim ® Gel is a safe and effective treatment option for use in the management of male hypogonadism.