Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 4
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 Erectile Dysfunction, Vardenafil
Eligibility Criteria
Inclusion Criteria:
- Men >/= 18 years of age,
- ED 6 months or longer
- 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
- Other exclusion criteria apply according to the Summary of Product Characteristics
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
International Index of Erectile Function - Erectile Function Domain
Secondary Outcome Measures
Sexual Encounter Profile Question 2 and 3
Global Assessment Question
Other diary based variables
Safety and tolerability
Full Information
NCT ID
NCT00681772
First Posted
April 18, 2008
Last Updated
December 10, 2014
Sponsor
Bayer
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00681772
Brief Title
Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
Official Title
Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
333 (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
5mg, 10mg or 20mg taken 1 hours before sexual intercourse
Primary Outcome Measure Information:
Title
International Index of Erectile Function - Erectile Function Domain
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sexual Encounter Profile Question 2 and 3
Time Frame
12 weeks
Title
Global Assessment Question
Time Frame
12 weeks
Title
Other diary based variables
Time Frame
12 weeks
Title
Safety and tolerability
Time Frame
12 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,
ED 6 months or longer
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
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
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
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