COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786253
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : October 28, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg on demand use

Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil daily dosing 10 mg

Primary Outcome Measures :
  1. 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 Measures :
  1. SEP 2 [ Time Frame: 12- 24 weeks ]
  2. SEP 3 [ Time Frame: 12- 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786253

Layout table for location information
Tübingen, Baden-Württemberg / 277, Germany, 72076
München, Bayern / 280, Germany, 81925
Regensburg, Bayern / 280, Germany, 93053
Weiden, Bayern / 280, Germany, 92637
Berlin, Berlin / 285, Germany, 12200
Hamburg, Hamburg / 287, Germany, 20251
Hamburg, Hamburg / 287, Germany, 20354
Hamburg, Hamburg / 287, Germany, 22299
Marburg, Hessen / 307, Germany, 35039
Hagenow, Mecklenburg-Vorpommern / 309, Germany, 19230
Hannover, Niedersachsen / 291, Germany, 30625
Osnabrück, Niedersachsen / 293, Germany, 49076
Düsseldorf, Nordrhein-Westfalen / 296, Germany, 40225
Münster, Nordrhein-Westfalen / 298, Germany, 48149
Leverkusen, Nordrhein-Westfalen / 331, Germany, 51375
Grevenbroich, Nordrhein-Westfalen / 623, Germany, 41515
Leipzig, Sachsen / 313, Germany, 04249
Meißen, Sachsen / 313, Germany, 01662
Halle, Sachsen-Anhalt / 311, Germany, 06097
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Additional Information:
Layout table for additonal information
Responsible Party: Bayer Identifier: NCT00786253    
Other Study ID Numbers: 11875
EudraCT No: 2005-001678-28
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Erectile dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents