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Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: February 25, 2008
Last updated: October 27, 2014
Last verified: October 2014

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 Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • SEP 2 [ Time Frame: 12- 24 weeks ]
  • SEP 3 [ Time Frame: 12- 24 weeks ]

Enrollment: 236
Study Start Date: October 2005
Study Completion Date: January 2007
Arms Assigned Interventions
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


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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00786253

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00786253     History of Changes
Other Study ID Numbers: 11875
EudraCT No: 2005-001678-28
Study First Received: February 25, 2008
Last Updated: October 27, 2014

Keywords provided by Bayer:
Erectile dysfunction

Additional relevant 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 processed this record on April 24, 2017