Pivotal study: Multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men with an average serum testosterone concentration <300 ng/dL as determined by two morning samples collected on the same day. Patients were initially randomized to receive 40.5 mg of AndroGel 1.62% or matching placebo. Patients returned to the clinic on Days 14, 28, and 42 for pre-dose serum total testosterone assessments, and their daily dose was titrated up or down in 20.25 mg increments if their level was outside the range of 350–750 ng/dL. Patients could have received any of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily) or placebo during the 182-day treatment period. The primary endpoint was the percentage of patients with an average serum testosterone level within the normal range (300–1000 ng/dL) on Day 112. Patients could agree to continue in an open-label, active-treatment maintenance period for an additional 182 days.1,2
Open-label extension study: Safety and efficacy of AndroGel 1.62% were assessed in an open-label, active-treatment, noncomparative maintenance study. 191 patients who completed the randomized, double-blind, parallel-group, placebo-controlled study entered the 182-day open-label extension period. Patients could have received any of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily).1