European Urology
Volume 50, Issue 5 , Pages 1086-1095 , November 2006

Extended Duration of Efficacy of Vardenafil When Taken 8 Hours Before Intercourse: A Randomized, Double-Blind, Placebo-Controlled Study

  • Hartmut Porst

      Affiliations

    • Urological Practice, Hamburg, Germany
    • Corresponding Author InformationCorresponding author. Urological Practice, Neuer Jungfernstieg 6a, 20354 Hamburg, Germany. Tel. +49 40 34 61 84; Fax: +49 40 35 11 17.
  • ,
  • Ira D. Sharlip

      Affiliations

    • University of California, San Francisco, California, USA
  • ,
  • Dimitris Hatzichristou

      Affiliations

    • Aristotle University of Thessaloniki, Thessaloniki, Greece
  • ,
  • Eusebio Rubio-Aurioles

      Affiliations

    • Asociación Mexicana Para la Salud Sexual, Tlalpan, Mexico
  • ,
  • Marc Gittelman

      Affiliations

    • South Florida Medical Research, Aventura, Florida, USA
  • ,
  • Britt-Nicole Stancil

      Affiliations

    • GlaxoSmithKline, Research Triangle Park, North Carolina, USA
  • ,
  • Peter M. Smith

      Affiliations

    • GlaxoSmithKline, Research Triangle Park, North Carolina, USA
  • ,
  • H. Jeffrey Wilkins

      Affiliations

    • GlaxoSmithKline, King of Prussia, Pennsylvania, USA
  • ,
  • Peter Pommerville

      Affiliations

    • Can-Med Clinical Research Inc., Victoria, British Columbia, Canada
  • ,
  • for the Vardenafil Study Group

,Accepted 18 May 2006.

  • Image Result

    Patient disposition and reasons for withdrawal.

    Patient disposition and reasons for withdrawal.

  • Image Result

    LS mean success rates for maintaining an erection that led to successful sexual intercourse (SEP3) and inserting the penis into the partner's vagina (SEP2) at baseline and overall for weeks 2–10 (the

    LS mean success rates for maintaining an erection that led to successful sexual intercourse (SEP3) and inserting the penis into the partner's vagina (SEP2) at baseline and overall for weeks 2–10 (the period after the initial titration phase). LS=least squares; SEP=Sexual Encounter Profile Question.

  • Image Result
    Overall mean success rates during weeks 2–10 (the period after the initial titration phase) for (1) maintaining an erection that led to successful sexual intercourse (SEP3) and (2) inserting the penis

    Overall mean success rates during weeks 2–10 (the period after the initial titration phase) for (1) maintaining an erection that led to successful sexual intercourse (SEP3) and (2) inserting the penis into the partner's vagina (SEP2) at hourly intervals 6–10hours postdose. SEP=Sexual Encounter Profile Question.

  • Image Result
    LS mean IIEF-EF domain scores at baseline and after the initial titration phase at weeks 2–6, 6–10 and week 10 LOCF (intent-to-treat population). LS=least squares; IIEF-EF=International Index of Erect

    LS mean IIEF-EF domain scores at baseline and after the initial titration phase at weeks 2–6, 6–10 and week 10 LOCF (intent-to-treat population). LS=least squares; IIEF-EF=International Index of Erectile Function-Erectile Function; LOCF=last observation carried forward.

  • Image Result
    Percentage of patients with a positive response to the GAQ (“Has the treatment you have been taking over the last 4 weeks improved your erections? (Y/N)”) after the initial titration phase at weeks 2–

    Percentage of patients with a positive response to the GAQ (“Has the treatment you have been taking over the last 4 weeks improved your erections? (Y/N)”) after the initial titration phase at weeks 2–6, 6–10 and week 10 LOCF (intent-to-treat population). GAQ=Global Assessment Question; LOCF=last observation carried forward.

PII: S0302-2838(06)00651-8

doi: 10.1016/j.eururo.2006.05.036

European Urology
Volume 50, Issue 5 , Pages 1086-1095 , November 2006