Trial Condition(s):
Erectile Dysfunction
Sustainable efficacy of vardenafil OD versus vardenafil PRN in erectile dysfunction
Bayer Identifier:
11875
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Osnabrück GmbH Osnabrück, Germany, 49076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Weiden Weiden, Germany, 92637 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. Grohmann München, Germany, 81925 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. H. Täschner Leipzig, Germany, 04249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D. Hennig Meißen, Germany, 01662 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Sperling Hamburg, Germany, 22299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. F. Merfort / M. Stammen / S. van Haag Grevenbroich, Germany, 41515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Leverkusen gGmbH Leverkusen, Germany, 51375 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diabetes-Forschungs-Institut Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Münster Münster, Germany, 48149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Universität Regensburg Regensburg, Germany, 93053 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitäts-Krankenhaus Eppendorf Hamburg, Germany, 20251 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. von Keitz Marburg, Germany, 35039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. Warnack Hagenow, Germany, 19230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)Timeframe: 12- 24 weeks
Secondary Outcome
- SEP 2Timeframe: 12- 24 weeks
- SEP 3Timeframe: 12- 24 weeks
Additional Information
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