Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
NCT ID: NCT00786253
Last Updated: 2014-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
236 participants
INTERVENTIONAL
2005-10-31
2007-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
NCT00668018
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
NCT00663130
Assessment of Duration of Erection With Vardenafil 10 mg
NCT00663728
Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
NCT00682019
A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction
NCT00665496
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg on demand use
Arm 2
Levitra (Vardenafil, BAY38-9456)
Vardenafil daily dosing 10 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg on demand use
Levitra (Vardenafil, BAY38-9456)
Vardenafil daily dosing 10 mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy.
18 Years
64 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tübingen, Baden-Württemberg / 277, Germany
München, Bayern / 280, Germany
Regensburg, Bayern / 280, Germany
Weiden, Bayern / 280, Germany
Berlin, Berlin / 285, Germany
Hamburg, Hamburg / 287, Germany
Hamburg, Hamburg / 287, Germany
Hamburg, Hamburg / 287, Germany
Marburg, Hessen / 307, Germany
Hagenow, Mecklenburg-Vorpommern / 309, Germany
Hanover, Niedersachsen / 291, Germany
Osnabrück, Niedersachsen / 293, Germany
Düsseldorf, Nordrhein-Westfalen / 296, Germany
Münster, Nordrhein-Westfalen / 298, Germany
Leverkusen, Nordrhein-Westfalen / 331, Germany
Grevenbroich, Nordrhein-Westfalen / 623, Germany
Leipzig, Sachsen / 313, Germany
Meißen, Sachsen / 313, Germany
Halle, Sachsen-Anhalt / 311, Germany
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT No: 2005-001678-28
Identifier Type: -
Identifier Source: secondary_id
RESTORE
Identifier Type: -
Identifier Source: secondary_id
11875
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.