check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11561

ClinicalTrials.gov Identifier:

NCT00665340

EudraCT Number:

Not Available

EU CT Number:

Not Available
Investigate the responsiveness of the Erectile Quality Scale to vardenafil flexible dose vs placebo in males with Erectile Dysfunction (ED)

Trial purpose

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older.
  • - Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information

Trial summary

Enrollment Goal
219
Trial Dates
July 2004 - January 2005
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hudson Valley Urology CenterPoughkeepsie, 12601, United States
Completed
New Havover Medical Research AssociatesWilmington, 28401, United States
Completed
The Lipid CenterStatesville, 28677, United States
Completed
Lawrenceville UrologyLawrenceville, 08648, United States
Completed
California Professional ResearchNewport Beach, 92660, United States
Completed
Clinical Research Consultants, Inc.Trumbull, 06611, United States
Completed
South Florida Medical ResearchAventura, 33180, United States
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Urology Research OptionsAurora, 80012, United States
Completed
The Male ClinicBeverly Hills, 90212, United States
Terminated
Clinical Research Associates, Inc.Nashville, 37203, United States
Completed
South Coast Urological Medical GroupLaguna Hills, 92653, United States

Primary Outcome

  • Erection Quality Scale
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Erection Quality Scale
    date_rangeTime Frame:
    Week 4 and 8
    enhanced_encryption
    Safety Issue:
    no
  • International Index of Erectile Function- Erectile Function domain score
    date_rangeTime Frame:
    Week 4 and 8
    enhanced_encryption
    Safety Issue:
    no
  • Per-subject success rates based on Sexual Encounter Profile, Question 2
    date_rangeTime Frame:
    Week 4, 8 Week 8
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    yes
  • Patient Diary Questions
    date_rangeTime Frame:
    Weeks 4, 8 Week 8
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question (GAQ)
    date_rangeTime Frame:
    Weeks 4, 8 of treatment and Week 8
    enhanced_encryption
    Safety Issue:
    no
  • Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
    date_rangeTime Frame:
    Week 8-LOCF
    enhanced_encryption
    Safety Issue:
    no
  • Penetration (SEP2) and Maintenance (SEP3) reliability
    date_rangeTime Frame:
    Week 8-LOCF
    enhanced_encryption
    Safety Issue:
    no

Trial design

A randomized, double blind, placebo-controlled, parallel group, multi-center study to investigate the responsiveness of the Erectile Quality Scale (EQS) to vardenafil HCl flexible dose versus placebo in males with erectile dysfunction.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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