title: Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED.
  
  
  METHODS
  This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25mg, 50mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study.
  
  
  METHODS
  The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥ 26), and the response to the GAQ.
  
  
  CONCLUSIONS
  Compared with placebo, patients who took 50mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity.
  
  
  CONCLUSIONS
  Udenafil significantly improved erectile function among ED patients when administered in doses of 50mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50mg) may be another treatment option for ED.
authors: Department of Urology, Chonbuk National University Medical School, and Institute for Medical Sciences, Chonbuk National University, and Research Institute and CTC for Medical Device of Chonbuk National University Hospital, Jeonju, Korea.
authors: Chen
authors: C
authors: Zhao
authors: Sae Woong
authors: SW
authors: Kim
authors: Dae Yul
authors: DY
authors: Yang
authors: Je Jong
authors: JJ
authors: Kim
authors: Nam Cheol
authors: NC
authors: Park
authors: Sung Won
authors: SW
authors: Lee
authors: Jae Seung
authors: JS
authors: Paick
authors: Tai Young
authors: TY
authors: Ahn
authors: Kweon Sik
authors: KS
authors: Min
authors: Kwangsung
authors: K
authors: Park
authors: Jong Kwan
authors: JK
authors: Park
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D015990:Placebo Effect; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D056910:Republic of Korea; D012720:Severity of Illness Index; D012725:Sexual Behavior / Q000187:drug effects*; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides