Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00786253
First received: February 25, 2008
Last updated: October 18, 2013
Last verified: October 2013

February 25, 2008
October 18, 2013
October 2005
Not Provided
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 ]
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF) as observed in week 24-28 (treatment groups A, C) week 12-16 (treatment group B) [ Time Frame: 12- 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00786253 on ClinicalTrials.gov Archive Site
  • SEP 2 [ Time Frame: 12- 24 weeks ] [ Designated as safety issue: No ]
  • SEP 3 [ Time Frame: 12- 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Levitra (Vardenafil, BAY38-9456)
    Vardenafil 10 mg on demand use
  • Drug: Levitra (Vardenafil, BAY38-9456)
    Vardenafil daily dosing 10 mg
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Experimental: Arm 2
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
January 2007
Not Provided

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.
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00786253
11875, EudraCT No: 2005-001678-28, RESTORE
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP