Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men

Abstract

Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels. To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days. This was a multicenter, randomized, double-blind, placebo-controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate-specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42. Main Outcome Measures. The percentage of subjects with serum total testosterone average concentrations (C(av) ) within the normal range of 300-1,000 ng/dL on study days 14, 56, 112, and 182. Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone C(av) values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated. In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels.