Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Verified by: Bayer, June 2009
First Received: April 15, 2008 | Last Updated: June 12, 2009 | Phase: Phase 3 | Start Date: June 2003
Overall Status: Completed | Estimated Enrollment: 739
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Study to investigate the efficacy and safety of...

Brief Summary

Official Title: “A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction”

Study to investigate the efficacy and safety of Vardenafil

  • 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)
    • 10 mg Vardenafil to be taken 1 h prior to sexual attempt
  • Drug: Placebo
    • Matching placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
  • Placebo Comparator: Arm 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Sexual Encounter Profile question 2 (SEP 2)
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • Sexual Encounter Profile question 3 (SEP 3)
    • Time Frame: 12 weeks
      Safety Issue?: No
  • International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Safety and Tolerability
    • Time Frame: 12 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Heterosexual males
  • >/= 18 years old with ED for more than six months
  • Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
  • Other exclusion criteria apply according to the Summary of Product Characteristics

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

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/NCT00661297

Study ID Number: 100536

ClinicalTrials.gov Identifier: NCT00661297

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00661297