Back to 2011 Program

Introduction: This post hoc analysis examined the effect of body mass index (BMI) on testosterone (T) replacement therapy (TRT) in hypogonadal males (HM).
Materials & Methods: In a non-comparative trial, 129 HM with serum total T (STT) <250ng/dL or 2 consecutive STT concentrations <300ng/dL received once-daily T2% gel (Fortesta™, a new formulation applied to the front and inner thigh) for 90d. Starting dose was 40mg/day, adjusted on days 14, 35 and 60 if necessary according to predefined criteria in 10mg increments. BMI measurements were collected at baseline. Endpoints were average STT concentration over 24h (C_avg 0-24h) and maximum STT concentration (C_max) at 90d. Study Objective was to raise STT C_avg 0-24h to a normal range of ≥300 and ≤1140ng/dL in ≥75% patients.
Results: At baseline, 8 patients (6%) had normal weight (BMI ≥18.5-≤24.9kg/m²); 43 patients (33%) were overweight (BMI ≥25-≤29.9kg/m²); and 78 patients (61%) were obese (BMI ≥30kg/m²). Mean STT levels at baseline were 199.8 92.1ng/dL, 190.3 69.4ng/dL and 198.5 63.1ng/dL, respectively. STT concentrations at 35d and 90d were comparable across treatment groups (Table). T2% gel was generally well tolerated and most common adverse incidents were application-site reactions (16%) considered mild (19/24; 79%) to moderate (5/24; 21%).
Conclusions: Regardless of baseline BMI, patients responded similarly to T2% gel to maintain STT levels.