(067) Oral Testosterone, Is It Ready for Prime Time? A Meta-analysis of Safety and Efficacy in Men with Testosterone Deficiency

Abstract

Abstract Introduction The prescription rates of testosterone replacement therapy (TRT) have tripled within recent decades. Recently, two novel oral testosterone undecanoate (TU) options have obtained FDA approval and are now commercially available. We present the first meta-analysis analyzing the safety and efficacy of oral TRT in patients with testosterone deficiency (TD). Objective To evaluate the safety and efficacy of TU in the treatment of TD Methods Pair-wise meta-analyses were performed including randomized, placebo-controlled trials investigating the use of TU. Studies were included for analysis if participants received oral TRT or placebo for a period greater than one month and if adverse effects (AE) or changes in serum total testosterone (TT) were recorded. Results Nine studies including a total of 606 patients recorded changes in TT. When separated by population, studies including only men with TD saw improved TT (mean change 1.25 ng/mL, 95% CI: 0.22 to 2.29, I2: 0%). Eight studies including a total of 849 patients recorded rates of AE. There was no statistically significant change in the risk of AE in patients receiving oral TRT compared to placebo (log risk ratio -0.03, 95% CI: -0.08 to 0.03, I2: 0%) [Figure 1]. Conclusions When separated by inclusion criteria, studies examining men with TD tended to report improved TT levels following treatment with TU compared to placebo. In studies examining the safety of oral TRT, its use was not associated with increased rates of AE when compared with placebo. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Antares Pharma; Clarus Therapeutics; Coloplast; Cynosure; Promescent; Sprout; Viome.