Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Verified by: Bayer, March 2010
First Received: April 24, 2008 | Last Updated: March 8, 2010 | Phase: Phase 3 | Start Date: January 2003
Overall Status: Completed | Estimated Enrollment: 1200
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Assess efficacy of vardenafil within 6 hours after...

Brief Summary

Official Title: “An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug”

Assess efficacy of vardenafil within 6 hours after intake

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Levitra (Vardenafil, BAY38-9456)
    • Vardenafil 10mg orally on demand prior to intercourse

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • International Index of Erectile Function
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Global Assessment Question (GAQ)
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Other diary responses
    • Time Frame: 12 weeks
      Safety Issue?: No
  • General Safety
    • Time Frame: 12 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Age: 18 years and older
  • Males with erectile dysfunction
  • Stable heterosexual relationship

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
  • Nitrate use

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/NCT00668018

Study ID Number: 10678

ClinicalTrials.gov Identifier: NCT00668018

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00668018