Back to resultsBAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Levitra (Vardenafil, BAY38-9456)
Levitra (Vardenafil, BAY38-9456)
Placebo
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Male Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
- Stable heterosexual relationship
Exclusion Criteria:
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
- Nitrate use
- Other exclusion criteria apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Description
Outcomes
Primary Outcome Measures
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
Secondary Outcome Measures
Global Assessment Questionnaire
Erectile Function domain score of the International Index of Erectile Function
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668057
Brief Title
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Official Title
Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 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
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
624 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Title
Arm 5
Arm Type
Placebo Comparator
Arm Title
Arm 6
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
5 mg Vardenafil orally 1 hour prior to sexual intercourse
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
10 mg Vardenafil orally 1 hour prior to sexual intercourse
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
20 mg Vardenafil orally 1 hour prior to sexual intercourse
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 mg matching placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 mg matching placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
20 mg matching placebo
Primary Outcome Measure Information:
Title
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Global Assessment Questionnaire
Time Frame
12 weeks
Title
Erectile Function domain score of the International Index of Erectile Function
Time Frame
12 weeks
Title
Safety and tolerability
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
Stable heterosexual relationship
Exclusion Criteria:
Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
Nitrate use
Other exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
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BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
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