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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on August 29, 2008

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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