PII-LBA6 EFFECT OF TESTOSTERONE SOLUTION ON TOTAL TESTOSTERONE, SEX DRIVE AND ENERGY IN HYPOGONADAL MEN

Abstract

You have accessJournal of UrologyPlenary Session II – Late Breaking Abstracts1 Apr 2015PII-LBA6 EFFECT OF TESTOSTERONE SOLUTION ON TOTAL TESTOSTERONE, SEX DRIVE AND ENERGY IN HYPOGONADAL MEN Gerald Brock, Darell Heiselman, Mario Maggi, Sae Woong Kim, José Maria Rodríguez Vallejo, Hermann Behre, John McGettigan, Sherie Dowsett, Jack Knorr, Xiao Ni, and Kraig Kinchen Gerald BrockGerald Brock More articles by this author , Darell HeiselmanDarell Heiselman More articles by this author , Mario MaggiMario Maggi More articles by this author , Sae Woong KimSae Woong Kim More articles by this author , José Maria Rodríguez VallejoJosé Maria Rodríguez Vallejo More articles by this author , Hermann BehreHermann Behre More articles by this author , John McGettiganJohn McGettigan More articles by this author , Sherie DowsettSherie Dowsett More articles by this author , Jack KnorrJack Knorr More articles by this author , Xiao NiXiao Ni More articles by this author , and Kraig KinchenKraig Kinchen More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.03.086AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There is a paucity of randomized clinical trial data on the effects of testosterone therapy on symptoms of hypogonadism, including decreased sex drive and energy level. We assessed the effect of testosterone solution 2% (Axiron®) on serum total testosterone (TT) concentration and on these 2 common symptoms in hypogonadal men. METHODS In this randomized, double-blind study, hypogonadal men ≥18 years (serum TT <300 ng/dL) were assigned testosterone or placebo for 12 weeks. The primary objective was to compare the effect of testosterone and placebo on the proportion of hypogonadal men with TT within the normal range (300-1050 ng/dL) at study completion. Secondary objectives were to assess the effect of testosterone on sexual drive and energy level using two new patient-reported outcome instruments, the Sexual Arousal, Interest, and Drive (SAID) Scale and the Hypogonadism Energy Diary (HED), respectively. RESULTS Overall, 715 men (mean age 55 years) were randomized to placebo (n=357) or testosterone (n=358); 82% assigned placebo and 84% assigned testosterone completed the study. The number of men with TT within the normal range (300-1050 ng/dL) after 12 weeks of treatment was 217 (73%) in the testosterone group versus 43 (15%) in placebo (p<0.001). SAID and HED findings are shown (table). Discontinuations due to adverse events did not differ (placebo, 3%; testosterone, 2%. P=0.48). There were no significant treatment group differences in reporting of adjudicated CV events (stroke, MI, unstable angina) (placebo, 2; testosterone, 0) or venous thromboembolic events (placebo, 1; testosterone, 0). At endpoint, elevated PSA (>4ng/mL) was reported in 6 subjects assigned testosterone and 2 assigned placebo (p=0.29), and elevated hematocrit (>54%) was reported in 4 assigned testosterone and 1 assigned placebo (p=0.22). CONCLUSIONS Testosterone therapy in men with hypogonadism resulted in TT concentration levels returning to the normal range in the majority of cases. Hypogonadal men receiving testosterone reported statistically significant improvements in sex drive but not energy levels at p<0.01 level. The safety findings are consistent with those of prior studies of testosterone solution in hypogonadal men; no new safety concerns were identified. Summary of SAID and HED findings (LS mean change [SE])a Placebo (N=357)b Testosterone solution 2% (N=358)b LS mean difference Adjusted P value SAID scale 6.3 (0.99) 11.4 (1.02) 5.1 (1.05, 9.07) <.001 HED scale 7.5 (0.87) 10.5 (0.89) 2.9 (-0.59, 6.45) 0.019c a Analysis of covariance was used to evaluate baseline-to-endpoint (12 week/LOCF) change. b Number of randomized subjects. SAID findings are calculated for the low sex drive dataset (placebo, n=308; testosterone, n=311). HED findings are calculated for the low energy dataset (placebo, n=318; testosterone, n=318). c Not significant at the pre-specified p < 0.01 level. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e497 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Gerald Brock More articles by this author Darell Heiselman More articles by this author Mario Maggi More articles by this author Sae Woong Kim More articles by this author José Maria Rodríguez Vallejo More articles by this author Hermann Behre More articles by this author John McGettigan More articles by this author Sherie Dowsett More articles by this author Jack Knorr More articles by this author Xiao Ni More articles by this author Kraig Kinchen More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...