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

Verified by: Bayer, June 2009
First Received: April 17, 2008 | Last Updated: June 29, 2009 | Phase: Phase 4 | Start Date: April 2004
Overall Status: Completed | Estimated Enrollment: 759
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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...

Brief Summary

Official Title: “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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
  • Active Comparator: Arm 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Sexual Encounter Profile Question 3 (SEP-3)
    • Time Frame: 4 weeks
      Safety Issue?: No

Secondary Measures

  • Sexual Encounter Profile Question 2 (SEP-2)
    • Time Frame: 4 weeks
      Safety Issue?: No
  • International Index of Erectile Function
    • Time Frame: 4 weeks
      Safety Issue?: No
  • Global Confidence Question (GCQ)
    • Time Frame: 4 weeks
      Safety Issue?: No
  • Erection Quality Scale (EQS)
    • Time Frame: 4 weeks
      Safety Issue?: No
  • General Safety
    • Time Frame: 4 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663130

Study ID Number: 11333

ClinicalTrials.gov Identifier: NCT00663130

Health Authority: United States: Food and Drug Administration

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