title: Safety and efficacy of once daily administration of 50 mg mirodenafil in patients with erectile dysfunction: a multicenter, double-blind, placebo controlled trial.
abstract: OBJECTIVE
  We evaluated the improvement in erectile dysfunction and lower urinary tract symptoms as well as the safety of once daily administration of 50 mg mirodenafil in men with erectile dysfunction.
  
  
  METHODS
  A total of 226 patients visited for treatment of erectile dysfunction and were recruited for the study. Of these men 180 met the study inclusion criteria after completing a 2-week screening period (visit [V]1). The patients were randomly allocated into 2 groups. Group 1 (90 patients) received 50 mg mirodenafil once daily and group 2 (90 patients) received a placebo daily. Blood pressure, heart rate, IIEF-5 (5-item version of the International Index of Erectile Function), and SEP (Sexual Encounter Profile) questions 2 and 3 were assessed at 4 (V2), 8 (V3) and 12 weeks after the start of treatment (V4). I-PSS (International Prostate Symptom Score), maximal flow rate and post-void residual volume were also assessed for the evaluation of lower urinary tract symptoms.
  
  
  RESULTS
  Of the 180 patients 71 in group 1 and 63 in group 2 completed the 12-week clinical trial. IIEF-5 and I-PSS significantly improved in group 1 (p <0.001 for both). Facial flushing was the most common adverse effect, followed by headaches. Notably there were no statistically significant differences in either of the variables related to the cardiovascular system.
  
  
  CONCLUSIONS
  Once daily administration of 50 mg mirodenafil was efficacious and safe for the treatment of erectile dysfunction and lower urinary tract symptoms.
authors.affiliation: Department of Urology, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Chung
authors.forename: Dong Hyuk
authors.initials: DH
authors.lastname: Kang
authors.forename: Cheol Young
authors.initials: CY
authors.lastname: Oh
authors.forename: Jae Min
authors.initials: JM
authors.lastname: Chung
authors.forename: Ki Soo
authors.initials: KS
authors.lastname: Lee
authors.forename: Tae Hyo
authors.initials: TH
authors.lastname: Kim
authors.forename: Kyung Hyun
authors.initials: KH
authors.lastname: Moon
authors.forename: Wan
authors.initials: W
authors.lastname: Lee
authors.forename: Jeong Man
authors.initials: JM
authors.lastname: Cho
authors.forename: Seung Wook
authors.initials: SW
authors.lastname: Lee
mesh_terms: D000284:Administration, Oral; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage; D011744:Pyrimidinones / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D011744:Pyrimidinones; D013449:Sulfonamides; C528396:mirodenafil