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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00656188
First received: April 4, 2008
Last updated: October 9, 2013
Last verified: October 2013

April 4, 2008
October 9, 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 ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Question [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reliability of insertion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reliability of maintenance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Other subject diary based variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00656188
10898, GSK 001
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