Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Verified by: Bayer, October 2008
First Received: April 25, 2008 | Last Updated: October 7, 2008 | Phase: Phase 4 | Start Date: March 2003
Overall Status: Completed | Estimated Enrollment: 413
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To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction...

Brief Summary

Official Title: “Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-Centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia”

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (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: Vardenafil (Levitra, BAY38-9456)
    • Vardenafil 10 mg orally on demand prior to intercourse
  • 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

  • International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • Global Assessment Question
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Other diary responses
    • 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:

  • Age: 20 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
  • Other exclusion criteria apply according to the Summary of Product Characteristics

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 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/NCT00668135

Study ID Number: 10657

ClinicalTrials.gov Identifier: NCT00668135

Health Authority: Malaysia: Ministry of Health

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00668135