title: Testosterone Replacement in Androgen-Deficient Men With Ejaculatory Dysfunction: A Randomized Controlled Trial.
abstract: BACKGROUND
  Low T levels have been associated with ejaculatory dysfunction (EjD) in cross-sectional studies; however, the efficacy of T replacement in improving EjD has not been studied in a randomized controlled trial.
  
  
  OBJECTIVE
  To evaluate the efficacy of T replacement in androgen-deficient men with EjD.
  
  
  METHODS
  A multicenter, double-blind, randomized, placebo-controlled, 16-week trial with T solution 2% versus placebo.
  
  
  METHODS
  Medical centers in the United States, Canada, and Mexico.
  
  
  METHODS
  Seventy-six men with one or more EjD symptoms, including delayed ejaculation, anejaculation, reduced ejaculate volume, and/or reduced force of ejaculation, and two total T levels <300 ng/dL (<10.41 nmol/L) measured with liquid chromatography tandem mass spectrometry.
  
  
  METHODS
  Sixty milligrams of T solution 2% or placebo applied to the axillae for 16 weeks.
  
  
  METHODS
  The primary outcome was a change in the score of the three-item Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF); secondary outcomes included measured ejaculate volume, scores of the bother/satisfaction item of the MSHQ-EjD-SF, the orgasmic function domain of the International Index of Erectile Function Questionnaire, and the sexual activity log.
  
  
  RESULTS
  Seventy-six participants were randomized; 66 completed the study. Baseline demographic and clinical characteristics were comparable between the treatment arms. T replacement improved the MSHQ-EjD-SF score (mean score change, +3.1); however, this effect was not statistically different from placebo (mean score change, +2.5; P = .596). No differences were seen in any of the secondary outcomes or frequency of adverse events.
  
  
  CONCLUSIONS
  T replacement was not associated with significant improvement in EjD in androgen-deficient men.
authors.affiliation: Department of Urology (D.A.P.), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P.K.P., X.N.), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.
authors.forename: Darius A
authors.initials: DA
authors.lastname: Paduch
authors.affiliation: Department of Urology (D.A.P.), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P.K.P., X.N.), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.
authors.forename: Paula K
authors.initials: PK
authors.lastname: Polzer
authors.affiliation: Department of Urology (D.A.P.), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P.K.P., X.N.), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.
authors.forename: Xiao
authors.initials: X
authors.lastname: Ni
authors.affiliation: Department of Urology (D.A.P.), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P.K.P., X.N.), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.
authors.forename: Shehzad
authors.initials: S
authors.lastname: Basaria
mesh_terms: D000328:Adult; D000728:Androgens / Q000172:deficiency*; D004311:Double-Blind Method; D004542:Ejaculation / Q000187:drug effects; D005058:Eunuchism / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D020249:Hormone Replacement Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010919:Placebos; D012735:Sexual Dysfunction, Physiological / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D013739:Testosterone / Q000097:blood / Q000627:therapeutic use*
chemical_list: D000728:Androgens; D010919:Placebos; D013739:Testosterone