title: Extended duration of efficacy of vardenafil when taken 8 hours before intercourse: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  This study explored the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours before sexual intercourse.
  
  
  METHODS
  A 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20mg) was conducted in men with ED for >6 months who failed >or=50% of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout.
  
  
  RESULTS
  383 patients were randomized to vardenafil (n=194) or placebo (n=189). Patients treated with vardenafil 8 hours before sexual activity achieved clinically meaningful (>or=18%) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2-10, compared with patients receiving placebo (SEP3 69% vs 34%; SEP2 81% vs 51%; both p<0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p<0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p<0.001). Vardenafil was generally well tolerated.
  
  
  CONCLUSIONS
  The extended duration of efficacy of vardenafil up to 8 hours postdose may provide couples with more flexibility in their sexual life than anticipated.
authors.affiliation: Urological Practice, Hamburg, Germany. Porst20354@aol.com
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
authors.forename: Ira D
authors.initials: ID
authors.lastname: Sharlip
authors.forename: Dimitris
authors.initials: D
authors.lastname: Hatzichristou
authors.forename: Eusebio
authors.initials: E
authors.lastname: Rubio-Aurioles
authors.forename: Marc
authors.initials: M
authors.lastname: Gittelman
authors.forename: Britt-Nicole
authors.initials: BN
authors.lastname: Stancil
authors.forename: Peter M
authors.initials: PM
authors.lastname: Smith
authors.forename: H Jeffrey
authors.initials: HJ
authors.lastname: Wilkins
authors.forename: Peter
authors.initials: P
authors.lastname: Pommerville
mesh_terms: D000328:Adult; D000368:Aged; D003075:Coitus / Q000502:physiology*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
chemical_list: D007093:Imidazoles; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride