Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Verified by: Bayer, June 2009
First Received: April 16, 2008 | Last Updated: June 19, 2009 | Phase: Phase 4 | Start Date: September 2003
Overall Status: Completed | Estimated Enrollment: 102
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Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED)...

Brief Summary

Official Title: “Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals”

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

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

Intervention(s) in this Clinical Trial

  • Drug: Levitra (Vardenafil, BAY38-9456)
    • 10mg taken 1 hours before sexual intercourse

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1

Outcome Measures for this Clinical Trial

Primary Measures

  • International Index of Erectile Function- Erectile Function domain
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • Global Assessment Questionnaire (GAQ)
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Safety and tolerability
    • Time Frame: 8 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Men >/= 18 years of age
  • Erectile Dysfunction

Exclusion Criteria:

  • 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/NCT00662441

Study ID Number: 100578

ClinicalTrials.gov Identifier: NCT00662441

Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

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