Proven to restore testosterone levels in men with hypogonadism1,3
The 6-month study was specifically set up to assess pre-determined titration points at Days 14, 28, and 42. During the 6 months, 74% of patients were titrated due to below- or above-normal pre-dose serum total testosterone.3
The primary endpoint for this AndroGel 1.62% clinical study was the percent of men achieving an average pre-dose serum total testosterone level within the normal range (300-1000 ng/dL) on Day 112.1
Key findings included:
- 82% of men were within the average normal serum testosterone range on Day 112 with AndroGel 1.62% vs 37% with placebo (P<0.0001)3
- AndroGel 1.62% mean (SD) serum testosterone concentration on Day 112 (all doses) was 561 ng/dL (+/-259 ng/dL)1
Percent of subjects (95% CI) achieving total testosterone concentrations within the normal range (300-1000 ng/dL) during the 182-day double-blind period3
a40.5 mg daily dose.1
b20.25 mg, 40.5 mg, 60.75 mg, and 81 mg daily doses.1
Prior to Day 56, some patients were still being titrated with AndroGel 1.62%.1,3
Study Design: 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 percent 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.1,3
- Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events. Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically.
- Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products such as AndroGel 1.62%. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue AndroGel 1.62% and initiate appropriate workup and management.