check_circleStudy Completed

Erectile Dysfunction

Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 Years

Trial summary

Enrollment Goal
229
Trial Dates
October 2003 - August 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
The Male ClinicBeverly Hills, 90212, United States
Completed
St. Paul's Hospital - SaskatoonSaskatoon, S7M 0Z9, Canada
Completed
California Professional ResearchNewport Beach, 92660, United States
Completed
Prostate Cancer InstituteCalgary, T2V 4R6, Canada
Completed
San Diego Uro-ResearchSan Diego, 92101, United States
Completed
San Bernardino Urological AssociatesSan Bernardino, 92404, United States
Completed
Probity Medical Research/Urology AssociatesKitchener, N2M 5N4, Canada
Completed
Office of Dr. G.K.Jansz, MDBurlington, L7N 3V2, Canada
Completed
The Lipid CenterStatesville, 28677, United States
Completed
Male/Female Health & Research CentreBarrie, L4M 4S5, Canada
Completed
Scripps ClinicSan Diego, 92128, United States
Completed
Clinical Research Consultants, Inc.Trumbull, 06611, United States
Completed
Georgia Urology, PARiverdale, 30274, United States
Completed
Metrolina Medical Research AssociatesCharlotte, 28209, United States
Completed
St.Joseph's Health Care-LondonLondon, N6A 4V2, Canada
Completed
Robert Wood Johnson Medical SchoolNew Brunswick, 08901, United States
Completed
The Male Health CentresOakville, L6H 3P1, Canada
Completed
Dr.Peter J.Pommerville, Inc.Victoria, V8T 5G1, Canada
Completed
Radiant Research-IrvineIrvine, 92618-3603, United States
Completed
New Havover Medical Research AssociatesWilmington, 28412, United States
Completed
University Urology AssociatesNew York, 10016, United States
Completed
Lawrenceville UrologyLawrenceville, 08648, United States
Completed
Greenbelt Medical AssociatesGreenbelt, 20770, United States
Completed
Jacksonville Impotence Treatment CenterJacksonville, 32257, United States
Completed
Johns Hopkins at Greenspring StationLutherville, 21093, United States

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.
    date_rangeTime Frame:
    Weeks 0 -12
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • SEP3 at weeks 4 and 12 of treatment compared to placebo.
    date_rangeTime Frame:
    Weeks 4 and 12
    enhanced_encryption
    Safety Issue:
    no
  • 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
    date_rangeTime Frame:
    Weeks 4, 8 and 12
    enhanced_encryption
    Safety Issue:
    no
  • Global assessment question (GAQ) at weeks 4 and 12 of treatment compared to placebo
    date_rangeTime Frame:
    Weeks 4 and 12
    enhanced_encryption
    Safety Issue:
    no
  • Global confidence question (GCQ) at 12 weeks of treatment compared to placebo.
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no
  • The score for the IIEF questionnaire EF domain (IIEF-EF) at weeks 4, 12, and LOCF of treatment compared to placebo
    date_rangeTime Frame:
    Weeks 4 and 12
    enhanced_encryption
    Safety Issue:
    no
  • 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
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no
  • Scores from the mSLQQ-QOL at week 12 and LOCF of treatment compared to placebo
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no
  • Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) at week 12 of treatment compared to placebo.
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no

Trial design

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 dysfunction, and their female partners' sexual quality of life.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2