check_circleStudy Completed

Erectile Dysfunction

Efficacy and safety of vardenafil in men with erectile dysfunction

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 Years

Trial summary

Enrollment Goal
130
Trial Dates
August 2003 - March 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Municipal Clinical Hospital N50Moscow, 127206, Russia
Completed
Russian State Medical University of RoszdravMoscow, 117997, Russia
Completed
Research Institute of UrologyMoscow, 105425, Russia
Completed
Russian University of Peoples' FriendshipMoscow, 117198, Russia
Completed
Central Hospital of Railway MinistryMoscow, 123367, Russia
Completed
Research Centre of X-ray and RadiologyMoscow, 117837, Russia
Terminated
St Petersburg Military Medical AcademySt Petersburg, 198013, Russia
Completed
Russian Med Academy of Post Graduate EducationMoscow, 125101, Russia

Primary Outcome

  • Erectile Function (EF) domain score
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Erectile Function (EF) domain score
    date_rangeTime Frame:
    Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline of Erectile Function domain score
    date_rangeTime Frame:
    Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • IIEF domain scores
    date_rangeTime Frame:
    Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Patient Diary Questions
    date_rangeTime Frame:
    Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question (GAQ)
    date_rangeTime Frame:
    Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Premature termination, adverse events, laboratory abnormalities and concomitant medication usage
    date_rangeTime Frame:
    Week 4, 8 and 12
    enhanced_encryption
    Safety Issue:
    yes
  • Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    yes
  • Haematology, Clinical Chemistry, Urinalysis
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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 dysfunction of broad aetiology.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1