Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
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:
- Heterosexual males
- >/= 18 years old with ED for more than six months
- Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
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 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Sexual Encounter Profile question 2 (SEP 2)
Secondary Outcome Measures
Sexual Encounter Profile question 3 (SEP 3)
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
Safety and Tolerability
Full Information
NCT ID
NCT00661297
First Posted
April 15, 2008
Last Updated
December 1, 2014
Sponsor
Bayer
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00661297
Brief Title
Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
Official Title
A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 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
Study to investigate the efficacy and safety of Vardenafil
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
523 (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
10 mg Vardenafil to be taken 1 h prior to sexual attempt
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Sexual Encounter Profile question 2 (SEP 2)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sexual Encounter Profile question 3 (SEP 3)
Time Frame
12 weeks
Title
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
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:
Heterosexual males
>/= 18 years old with ED for more than six months
Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
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
Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
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