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Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656188
First Posted: April 10, 2008
Last Update Posted: October 10, 2013
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
April 4, 2008
April 10, 2008
October 10, 2013
October 2002
May 2003   (Final data collection date for primary outcome measure)
  • Erectile Function domain of the International Index of Erectile Function [ Time Frame: 12 weeks ]
  • Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ]
  • Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00656188 on ClinicalTrials.gov Archive Site
  • Erectile Function domain scores > 26 [ Time Frame: 12 weeks ]
  • Sexual Encounter Profile 2 [ Time Frame: 12 weeks ]
  • Global Assessment Question [ Time Frame: 12 weeks ]
  • Reliability of insertion [ Time Frame: 12 weeks ]
  • Reliability of maintenance [ Time Frame: 12 weeks ]
  • Other subject diary based variables [ Time Frame: 12 weeks ]
  • Safety and tolerability [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Levitra (Vardenafil, BAY38-9456)
    Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse
  • Drug: Placebo
    Matching placebo
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
  • Active Comparator: Arm 1
    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
463
May 2003
May 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for > 6 month

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 and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00656188
10898
GSK 001
Not Provided
Not Provided
Not Provided
Bayer
Bayer
GlaxoSmithKline
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