Levitra® - Real Life Safety and Efficacy of Levitra

Verified by: Bayer, June 2009
First Received: April 17, 2008 | Last Updated: June 5, 2009 | Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed | Estimated Enrollment: 30000
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Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction...

Brief Summary

Official Title: “REALISE Levitra® - Real Life Safety and Efficacy of Levitra”

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

  • 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)
    • Treatment according to US PI

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Improvement of Erectile Disfunction
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Onset of Drug Effect
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Second successful intercourse
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • General Safety Parameters
    • Time Frame: 8 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US
  • National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion Criteria:

  • Exclusion according to US PI

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/NCT00663598

Study ID Number: 100477

ClinicalTrials.gov Identifier: NCT00663598

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00663598