Text Size

Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00786253
First received: February 25, 2008
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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
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

  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
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, 22299
Hamburg, Hamburg / 287, Germany, 20354
Hamburg, Hamburg / 287, Germany, 20251
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00786253     History of Changes
Other Study ID Numbers: 11875, EudraCT No: 2005-001678-28, RESTORE
Study First Received: February 25, 2008
Last Updated: April 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Erectile dysfunction
Vardenafil

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013