Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
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:
- Males 18-64 years of age
- Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
- History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
- Stable, heterosexual relationship for more than six months
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
Secondary Outcome Measures
SEP 2
SEP 3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00786253
Brief Title
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
Official Title
A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (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
Compare once daily vs on demand treatment in men with erectile dysfunction.
Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:
A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
Vardenafil 10 mg on demand use
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
Vardenafil daily dosing 10 mg
Primary Outcome Measure Information:
Title
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
Time Frame
12- 24 weeks
Secondary Outcome Measure Information:
Title
SEP 2
Time Frame
12- 24 weeks
Title
SEP 3
Time Frame
12- 24 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:
Males 18-64 years of age
Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
Stable, heterosexual relationship for more than six months
Exclusion Criteria:
Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Tübingen
State/Province
Baden-Württemberg / 277
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern / 280
ZIP/Postal Code
81925
Country
Germany
City
Regensburg
State/Province
Bayern / 280
ZIP/Postal Code
93053
Country
Germany
City
Weiden
State/Province
Bayern / 280
ZIP/Postal Code
92637
Country
Germany
City
Berlin
State/Province
Berlin / 285
ZIP/Postal Code
12200
Country
Germany
City
Hamburg
State/Province
Hamburg / 287
ZIP/Postal Code
20251
Country
Germany
City
Hamburg
State/Province
Hamburg / 287
ZIP/Postal Code
20354
Country
Germany
City
Hamburg
State/Province
Hamburg / 287
ZIP/Postal Code
22299
Country
Germany
City
Marburg
State/Province
Hessen / 307
ZIP/Postal Code
35039
Country
Germany
City
Hagenow
State/Province
Mecklenburg-Vorpommern / 309
ZIP/Postal Code
19230
Country
Germany
City
Hannover
State/Province
Niedersachsen / 291
ZIP/Postal Code
30625
Country
Germany
City
Osnabrück
State/Province
Niedersachsen / 293
ZIP/Postal Code
49076
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen / 296
ZIP/Postal Code
40225
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen / 298
ZIP/Postal Code
48149
Country
Germany
City
Leverkusen
State/Province
Nordrhein-Westfalen / 331
ZIP/Postal Code
51375
Country
Germany
City
Grevenbroich
State/Province
Nordrhein-Westfalen / 623
ZIP/Postal Code
41515
Country
Germany
City
Leipzig
State/Province
Sachsen / 313
ZIP/Postal Code
04249
Country
Germany
City
Meißen
State/Province
Sachsen / 313
ZIP/Postal Code
01662
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt / 311
ZIP/Postal Code
06097
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
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