Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
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.
1 other identifier
interventional
219
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2004
Shorter than P25 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedOctober 11, 2013
October 1, 2013
6 months
April 18, 2008
October 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Erection Quality Scale
Week 8
Secondary Outcomes (8)
Erection Quality Scale
Week 4 and 8
International Index of Erectile Function- Erectile Function domain score
Week 4 and 8
Per-subject success rates based on Sexual Encounter Profile, Question 2
Week 4, 8 Week 8
Safety and tolerability
Week 8
Patient Diary Questions
Weeks 4, 8 Week 8
- +3 more secondary outcomes
Study Arms (2)
Arm 1
PLACEBO COMPARATORArm 2
EXPERIMENTALInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (12)
Unknown Facility
Phoenix, Arizona, 85023, United States
Unknown Facility
Beverly Hills, California, 90212, United States
Unknown Facility
Laguna Hills, California, 92653, United States
Unknown Facility
Newport Beach, California, 92660, United States
Unknown Facility
Aurora, Colorado, 80012, United States
Unknown Facility
Trumbull, Connecticut, 06611, United States
Unknown Facility
Aventura, Florida, 33180, United States
Unknown Facility
Lawrenceville, New Jersey, 08648, United States
Unknown Facility
Poughkeepsie, New York, 12601, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 23, 2008
Study Start
July 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
October 11, 2013
Record last verified: 2013-10