Back to resultsAssessment of Vardenafil in Patients With Erectile Dysfunction in Asia
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vardenafil (Levitra, 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:
- Age: 20 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
- Other exclusion criteria apply according to the Summary of Product Characteristics
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
International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
Secondary Outcome Measures
Global Assessment Question
Other diary responses
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668135
Brief Title
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
Official Title
Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (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
To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)
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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
348 (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)
Vardenafil (Levitra, BAY38-9456)
Intervention Description
Vardenafil 10 mg orally on demand prior to intercourse
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Global Assessment Question
Time Frame
12 weeks
Title
Other diary responses
Time Frame
12 weeks
Title
Safety and tolerability
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 20 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
Other exclusion criteria apply according to the Summary of Product Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hong Kong
Country
Hong Kong
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
City
Petlaing Jaya
State/Province
Salangor
ZIP/Postal Code
47500
Country
Malaysia
City
Kuching
State/Province
Sarawak
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
51200
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Manila
ZIP/Postal Code
150
Country
Philippines
City
Manila
Country
Philippines
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
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