title: Demographic and Clinical Correlates of Patient-Reported Improvement in Sex Drive, Erectile Function, and Energy With Testosterone Solution 2.
abstract: Evidence from well-designed studies documenting the benefit of testosterone replacement therapy as a function of patient demographic and clinical characteristics is lacking.
  
  
  
  To determine demographic and clinical predictors of treatment outcomes in hypogonadal men with low sex drive, low energy, and/or erectile dysfunction.
  
  
  
  Post hoc analysis of a randomized, multicenter, double-blinded, placebo-controlled, 16-week study of 715 hypogonadal men (mean age = 55.3 years, age range = 19-92 years) presenting with low sex drive and/or low energy who received placebo or testosterone solution 2% for 12 weeks.
  
  
  
  Two levels defined patient-reported improvement (PRI) in sex drive or energy: level 1 was at least "a little better" and level 2 was at least "much better" in energy or sex drive on the Patient Global Impression of Improvement at study end point. PRI in erectile function was stratified by erectile dysfunction severity at baseline as measured by the erectile function domain of the International Index for Erectile Function: mild at baseline (change of 2), moderate at baseline (change of 5), and severe at baseline (change of 7). Associations of demographic and clinical characteristics with PRI were calculated with stepwise forward multiple logistic regression analysis. Odds ratios represented the likelihood of PRI in symptoms among variable categories.
  
  
  
  Higher levels of end-point testosterone were associated with higher rates of PRI (at levels 1 and 2) in sex drive and energy (P < .001 for the two comparisons). Lower baseline testosterone levels were associated with higher rates of level 1 PRI in sex drive (P = .028); and classic hypogonadism (vs non-classic hypogonadism) was associated with higher rates of level 2 PRI in sex drive (P = .005) and energy (P = .006).
  
  
  
  When assessing the potential for improvements in men with testosterone deficiency using patient-reported outcome questionnaires, possible predictors of treatment outcomes to consider include the etiology of hypogonadism and testosterone levels (baseline and end point).
authors.affiliation: Centre for Endocrinology and Diabetes, Institute of Human Development, University of Manchester, Manchester, UK. Electronic address: frederick.wu@manchester.ac.uk.
authors.forename: Frederick
authors.initials: F
authors.lastname: Wu
authors.affiliation: Center for Reproductive Medicine and Andrology, Muenster, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Zitzmann
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Darell
authors.initials: D
authors.lastname: Heiselman
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Donatucci
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Jack
authors.initials: J
authors.lastname: Knorr
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Ankur B
authors.initials: AB
authors.lastname: Patel
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Kraig
authors.initials: K
authors.lastname: Kinchen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000728:Androgens / Q000627:therapeutic use*; D003710:Demography; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000209:etiology; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D007989:Libido / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010410:Penile Erection / Q000187:drug effects; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000728:Androgens; D013739:Testosterone
keywords: Androgen Deficiency; Energy; Hypogonadism; Sexual Desire; Testosterone Replacement Therapy