Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men.

摘要

INTRODUCTION: 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. AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.