This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 27, 2014
Last verified: October 2014
February 25, 2008
October 27, 2014
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 ]
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 ]
Complete list of historical versions of study NCT00786253 on ClinicalTrials.gov Archive Site
  • SEP 2 [ Time Frame: 12- 24 weeks ]
  • SEP 3 [ Time Frame: 12- 24 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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
236
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.
Sexes Eligible for Study: Male
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00786253
11875
EudraCT No: 2005-001678-28
RESTORE
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014

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