Gerald Brock1, Darell Heiselman2, Jack Knorr2, Xiao Ni2, Kraig Kinchen2. 1. Department of Surgery, University of Western Ontario, London, Ontario, Canada. Electronic address: gebrock@sympatico.ca. 2. Eli Lilly and Company, Indianapolis, Indiana.
Abstract
PURPOSE: We evaluated the continued safety and efficacy of testosterone solution 2% (T-sol) in a 6-month open label extension study following a 3-month, double-blind, placebo controlled study in which T-sol was safe and efficacious for sex drive in men with androgen deficiency. MATERIALS AND METHODS: A total of 558 hypogonadal participants with a mean (SD) age of 55 (11) years entered the open label treatment study. Of these patients 275 had previously received placebo (formerly placebogroup) and 283 had receivedactive treatment with T-sol (continuing active group) during the double-blind phase. Outcome measures were the proportion of men with total testosterone levels within the normal range; assessment of treatment induced change in sex drive measured using the Sexual Arousal, Interest, and Drive scale; and assessment of treatment induced change in energy measured using the Hypogonadism Energy Diary. RESULTS: At the completion of the open label phase 60% and 66% of the participants had total testosterone levels within the normal range in the formerly placebo and continuing active groups, respectively. Participants assigned to both groups showed baseline to end point improvement in Sexual Arousal, Interest, and Drive score (both p <0.001) and Hypogonadism Energy Diary score (both p <0.001) during the open label phase. No new safety concerns were reported. CONCLUSIONS: Once daily T-sol administered for 6 months in an open label study did not indicate new safety concerns, and the outcomes of low sex drive and low energy showed further improvement after the double-blind phase.
RCT Entities:
PURPOSE: We evaluated the continued safety and efficacy of testosterone solution 2% (T-sol) in a 6-month open label extension study following a 3-month, double-blind, placebo controlled study in which T-sol was safe and efficacious for sex drive in men with androgen deficiency. MATERIALS AND METHODS: A total of 558 hypogonadal participants with a mean (SD) age of 55 (11) years entered the open label treatment study. Of these patients 275 had previously received placebo (formerly placebo group) and 283 had received active treatment with T-sol (continuing active group) during the double-blind phase. Outcome measures were the proportion of men with total testosterone levels within the normal range; assessment of treatment induced change in sex drive measured using the Sexual Arousal, Interest, and Drive scale; and assessment of treatment induced change in energy measured using the Hypogonadism Energy Diary. RESULTS: At the completion of the open label phase 60% and 66% of the participants had total testosterone levels within the normal range in the formerly placebo and continuing active groups, respectively. Participants assigned to both groups showed baseline to end point improvement in Sexual Arousal, Interest, and Drive score (both p <0.001) and Hypogonadism Energy Diary score (both p <0.001) during the open label phase. No new safety concerns were reported. CONCLUSIONS: Once daily T-sol administered for 6 months in an open label study did not indicate new safety concerns, and the outcomes of low sex drive and low energy showed further improvement after the double-blind phase.
Authors: Biagio Barone; Luigi Napolitano; Marco Abate; Luigi Cirillo; Pasquale Reccia; Francesco Passaro; Carmine Turco; Simone Morra; Francesco Mastrangelo; Antonio Scarpato; Ugo Amicuzi; Vincenzo Morgera; Lorenzo Romano; Francesco Paolo Calace; Savio Domenico Pandolfo; Luigi De Luca; Achille Aveta; Enrico Sicignano; Massimiliano Trivellato; Gianluca Spena; Carlo D'Alterio; Giovanni Maria Fusco; Raffaele Vitale; Davide Arcaniolo; Felice Crocetto Journal: Int J Mol Sci Date: 2022-03-24 Impact factor: 5.923