Testosterone 2% Gel Can Normalize Testosterone Concentrations in Men with Low Testosterone Regardless of Body Mass Index. (1st March 2014)

• Record Type: Journal Article
• Authors: Dobs, Adrian; Norwood, Paul; Potts, Susan; Gould, Errol; Chitra, Surya
• Is Part Of: Journal of sexual medicine. Volume 11:Number 3(2014:Mar.)
• Page Start: 857
• Page End: 864
• Publication Date: 2014-03-01
• Subjects: Body Mass Index -- Hypogonadism -- Testosterone Replacement -- Transdermal Systemic Testosterone Gel; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1111/jsm.12411
• Languages: English
• ISSNs: 1743-6095

Abstract

Abstract: Introduction: Little is known about the effect of body mass index (BMI) on the efficacy and safety of testosterone therapy in hypogonadal men. A prior noncomparative trial demonstrated that testosterone 2% gel restored testosterone levels in hypogonadal men and was generally well tolerated. Aim: This post hoc analysis evaluated the influence of BMI on the pharmacokinetics of testosterone therapy in men with low testosterone. Methods: Men (N = 149) aged 18–75 applied testosterone 2% gel to the front and inner thigh once daily for 90 days. Starting dose was 40 mg/day, which could be adjusted at days 14, 35, and 60. Patients were split into categories depending on baseline BMI: Tertile 1 (≤29.1 kg/m 2 ), Tertile 2 (29.2–32.4 kg/m 2 ), and Tertile 3 (>32.4 kg/m 2 ). Main Outcome Measures: Efficacy end points were average serum total testosterone concentrations over 24 hours and maximum serum testosterone concentrations at day 90. Adverse events were recorded. Results: The efficacy analysis included 129 men with low testosterone (mean age 52.9, 54.0, and 54.2 years for Tertiles 1, 2, and 3, respectively) defined as serum testosterone <250–300 ng/dL. Baseline testosterone levels were comparable across BMI tertiles. After 90 days of treatment with testosterone 2% gel (≥40 mg/day), 79.1%, 79.5%, and 73.8% of patients in Tertiles 1, 2, and 3, respectively, achieved serum testosterone concentrations in the physiologic range (i.e., ≥ 300 to ≤ 1, 140 ng/dL). The mean average daily dose at day 90 was higher in participants in Tertiles 3 vs. 2 ( P = 0.039) and Tertiles 3 vs. 1 ( P = 0.010). The gel was generally well tolerated, with skin reactions the most commonly reported adverse event (16.1%; n = 24). Conclusions: In this study, daily application of testosterone 2% gel was effective at returning serum testosterone to physiologic levels in men with low testosterone and high BMI, although required dose was affected by BMI.