Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00786253

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 weeks C: PRN for 24 weeks

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)	Phase II

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Bayer:

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) [ Time Frame: 12- 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SEP 2 [ Time Frame: 12- 24 weeks ] [ Designated as safety issue: No ]
SEP 3 [ Time Frame: 12- 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	225
Study Start Date:	October 2005
Study Completion Date:	January 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg on demand use
Arm 2: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil daily dosing 10 mg

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786253

Locations

Germany, Baden-Württemberg / 277

Tübingen, Baden-Württemberg / 277, Germany, 72076
Germany, Bayern / 280

Regensburg, Bayern / 280, Germany, 93053

Weiden, Bayern / 280, Germany, 92637

München, Bayern / 280, Germany, 81925
Germany, Berlin / 285

Berlin, Berlin / 285, Germany, 12200
Germany, Hamburg / 287

Hamburg, Hamburg / 287, Germany, 20354

Hamburg, Hamburg / 287, Germany, 20251

Hamburg, Hamburg / 287, Germany, 22299
Germany, Hessen / 307

Marburg, Hessen / 307, Germany, 35039
Germany, Mecklenburg-Vorpommern / 309

Hagenow, Mecklenburg-Vorpommern / 309, Germany, 19230
Germany, Niedersachsen / 291

Hannover, Niedersachsen / 291, Germany, 30625
Germany, Niedersachsen / 293

Osnabrück, Niedersachsen / 293, Germany, 49076
Germany, Nordrhein-Westfalen / 296

Düsseldorf, Nordrhein-Westfalen / 296, Germany, 40225
Germany, Nordrhein-Westfalen / 298

Münster, Nordrhein-Westfalen / 298, Germany, 48149
Germany, Nordrhein-Westfalen / 331

Leverkusen, Nordrhein-Westfalen / 331, Germany, 51375
Germany, Nordrhein-Westfalen / 623

Grevenbroich, Nordrhein-Westfalen / 623, Germany, 41515
Germany, Sachsen / 313

Leipzig, Sachsen / 313, Germany, 04249

Meißen, Sachsen / 313, Germany, 01662
Germany, Sachsen-Anhalt / 311

Halle, Sachsen-Anhalt / 311, Germany, 06097

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	11875, EudraCT No: 2005-001678-28, RESTORE
Study First Received:	February 25, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00786253 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Erectile dysfunction
Vardenafil

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009