Trial Condition(s):

Erectile Dysfunction

Sustainable efficacy of vardenafil OD versus vardenafil PRN in erectile dysfunction

Bayer Identifier:

11875

ClinicalTrials.gov Identifier:

NCT00786253

EudraCT Number:

Not Available

Study Completed

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
236
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06097

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Klinikum Weiden

Weiden, Germany, 92637

Status
Completed
 
Locations

Praxis Hr. Dr. W. Grohmann

München, Germany, 81925

Status
Completed
 
Locations

Praxis Fr. Dr. H. Täschner

Leipzig, Germany, 04249

Status
Completed
 
Locations

Praxis Hr. Dr. D. Hennig

Meißen, Germany, 01662

Status
Completed
 
Locations

Praxis Hr. Dr. K. Sperling

Hamburg, Germany, 22299

Status
Completed
 
Locations

Praxis Drs. F. Merfort / M. Stammen / S. van Haag

Grevenbroich, Germany, 41515

Status
Completed
 
Locations

Klinikum Leverkusen gGmbH

Leverkusen, Germany, 51375

Status
Completed
 
Locations

Diabetes-Forschungs-Institut

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Completed
 
Locations

Klinikum der Universität Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Universitäts-Krankenhaus Eppendorf

Hamburg, Germany, 20251

Status
Completed
 
Locations

Praxis Hr. Dr. A. von Keitz

Marburg, Germany, 35039

Status
Completed
 
Locations

Praxis Hr. Dr. W. Warnack

Hagenow, Germany, 19230

Status
Completed
 

Trial Design