Back to resultsAssess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Male Erectile Dysfunction, Vardenafil
Eligibility Criteria
Inclusion Criteria:
- Age: 18 years and older
- Males with erectile dysfunction
- Stable heterosexual relationship
Exclusion Criteria:
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
Secondary Outcome Measures
International Index of Erectile Function
Global Assessment Question (GAQ)
Other diary responses
General Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668018
Brief Title
Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
Official Title
An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess efficacy of vardenafil within 6 hours after intake
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Male Erectile Dysfunction, Vardenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
887 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
Vardenafil 10mg orally on demand prior to intercourse
Primary Outcome Measure Information:
Title
Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
International Index of Erectile Function
Time Frame
12 weeks
Title
Global Assessment Question (GAQ)
Time Frame
12 weeks
Title
Other diary responses
Time Frame
12 weeks
Title
General Safety
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 years and older
Males with erectile dysfunction
Stable heterosexual relationship
Exclusion Criteria:
Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Nitrate use
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
Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
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