Clinical Trial: Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction

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

Official Title: Open-label Multi-centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-dose Regimen in Males With Erectile Dysfunctio

Brief Summary: To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Erectile Function (EF) domain score [ Time Frame: Week 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Erectile Function (EF) domain score [ Time Frame: Week 4, 8 and 12 Last Observation Carried Forward (LOCF) ]
  • Change from baseline of Erectile Function domain score [ Time Frame: Week 4, 8 and 12 Last Observation Carried Forward (LOCF) ]
  • IIEF domain scores [ Time Frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF) ]
  • Patient Diary Questions [ Time Frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF) ]
  • Global Assessment Question (GAQ) [ Time Frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF) ]
  • Premature termination, adverse events, laboratory abnormalities and concomitant medication usage [ Time Frame: Week 4, 8 and 12 ]
  • Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate [ Time Frame: Week 12 ]
  • Haematology, Clinical Chemistry, Urinalysis [ Time Frame: Week 12 ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: April 8, 2008
Date Started: August 2003
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014