Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Tadalafil
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 between 18 and 64 years
- Heterosexual males
- Erectile dysfunction for more than 6 months
Exclusion Criteria:
- Penile anatomical abnormalities
- Spinal cord injury
- History of surgical prostatectomy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Sexual Encounter Profile Question 3 (SEP-3)
Secondary Outcome Measures
Sexual Encounter Profile Question 2 (SEP-2)
International Index of Erectile Function
Global Confidence Question (GCQ)
Erection Quality Scale (EQS)
General Safety
Full Information
NCT ID
NCT00663130
First Posted
April 17, 2008
Last Updated
October 9, 2013
Sponsor
Bayer
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00663130
Brief Title
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
Official Title
A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 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
Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe 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
759 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse
Primary Outcome Measure Information:
Title
Sexual Encounter Profile Question 3 (SEP-3)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sexual Encounter Profile Question 2 (SEP-2)
Time Frame
4 weeks
Title
International Index of Erectile Function
Time Frame
4 weeks
Title
Global Confidence Question (GCQ)
Time Frame
4 weeks
Title
Erection Quality Scale (EQS)
Time Frame
4 weeks
Title
General Safety
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 64 years
Heterosexual males
Erectile dysfunction for more than 6 months
Exclusion Criteria:
Penile anatomical abnormalities
Spinal cord injury
History of surgical prostatectomy
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
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
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