Clinical Trial: Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double Blind, Parallel Group, Multi-center Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunctio

Brief Summary: Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner's sexual quality of life. [ Time Frame: Weeks 0 -12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SEP3 at weeks 4 and 12 of treatment compared to placebo. [ Time Frame: Weeks 4 and 12 ]
  • Additional Patient Diary questions at 4 weeks, 8 weeks, 12 weeks, LOCF, and over entire treatment period compared to placebo. Per-subject success rates will be calculated as the number of successes divided by the number of sexual attempts with a resp [ Time Frame: Weeks 4, 8 and 12 ]
  • Global assessment question (GAQ) at weeks 4 and 12 of treatment compared to placebo [ Time Frame: Weeks 4 and 12 ]
  • Global confidence question (GCQ) at 12 weeks of treatment compared to placebo. [ Time Frame: Week 12 ]
  • The score for the IIEF questionnaire EF domain (IIEF-EF) at weeks 4, 12, and LOCF of treatment compared to placebo [ Time Frame: Weeks 4 and 12 ]
  • Scores from the Treatment Satisfaction Scale (TSS) -- Subject Active Medication module at week 12 and LOCF of treatment compared to placebo. The TSS is a self-report measure of subject and partner's satisfaction with various aspects of erectile function [ Time Frame: Week 12 ]
  • Scores from the mSLQQ-QOL at week 12 and LOCF of treatment compared to placebo [ Time Frame: Week 12 ]
  • Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) at week 12 of treatment compared to placebo. [ Time Frame: Week 12 ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: April 9, 2008
Date Started: October 2003
Date Completion:
Last Updated: October 10, 2013
Last Verified: October 2013