Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Vardenafil
Eligibility Criteria
Inclusion Criteria:
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
- History of unresponsiveness to sildenafil
- Stable sexual relationship for > 6 month.
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Per-patient success rates based on Sexual Encounter Profile, Question 3
Secondary Outcome Measures
Per-subject success rates based on Sexual Encounter Profile, Question 2
International Index of Erectile Function- Erectile Function domain score
Global Assessment Question (GAQ)
Safety and tolerability
Full Information
NCT ID
NCT00682019
First Posted
April 18, 2008
Last Updated
October 10, 2013
Sponsor
Bayer
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00682019
Brief Title
Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, Vardenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
383 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
5mg, 10mg or 20mg taken 8 hours before sexual intercourse
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Per-patient success rates based on Sexual Encounter Profile, Question 3
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Per-subject success rates based on Sexual Encounter Profile, Question 2
Time Frame
10 weeks
Title
International Index of Erectile Function- Erectile Function domain score
Time Frame
10 weeks
Title
Global Assessment Question (GAQ)
Time Frame
10 weeks
Title
Safety and tolerability
Time Frame
10 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
History of unresponsiveness to sildenafil
Stable sexual relationship for > 6 month.
Exclusion Criteria:
Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
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