Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00663130
First received: April 17, 2008
Last updated: October 9, 2013
Last verified: October 2013

April 17, 2008
October 9, 2013
April 2004
July 2004   (final data collection date for primary outcome measure)
Sexual Encounter Profile Question 3 (SEP-3) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00663130 on ClinicalTrials.gov Archive Site
  • Sexual Encounter Profile Question 2 (SEP-2) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • International Index of Erectile Function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Global Confidence Question (GCQ) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Erection Quality Scale (EQS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • General Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Not Provided
Interventional
Phase 4
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 10mg, taken orally within 1 hour prior to sexual intercourse
  • Drug: Tadalafil
    Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Active Comparator: Arm 2
    Intervention: Drug: Tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
759
July 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 64 years
  • Heterosexual males
  • Erectile dysfunction for more than 6 months

Exclusion Criteria:

  • Penile anatomical abnormalities
  • Spinal cord injury
  • History of surgical prostatectomy
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00663130
11333
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