Official Title: “Multi-Centre, Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-Esteem and Self Confidence in Subjects With Erectile Dysfunction.”

Purpose of the study is: - To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo - To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
• Drug: Placebo
  • Matching placebo tablets orally prior to sexual activity

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• LOCF improved compared to baseline GAQ results at the end of the study
  • Time Frame: baseline versus visit 2 visit 5 or premature termination visit
    Safety Issue?: No

Secondary Measures

• IIEF scores
  • Time Frame: visits 3, 4 and 5
    Safety Issue?: No
• OF, SD, IS scores in IIEF Questionnaire
  • Time Frame: visits 2, 3, 4, 5 or at premature termination visit
    Safety Issue?: No
• Scores of all individual questions on IIEF questionnaire
  • Time Frame: visits 2, 3, 4, 5 or at premature termination visit
    Safety Issue?: No
• Subject's diary response
  • Time Frame: baseline and after randomization per visit period
    Safety Issue?: No
• SSES-E scores
  • Time Frame: visits 2 and 5 or premature termination visit
    Safety Issue?: No
• Summary score from the responses to SSES-E
  • Time Frame: visits 2 and 5 or premature termination visit
    Safety Issue?: No
• Response scores and summary score from the responses to the SF-36
  • Time Frame: visits 2 and 5 or premature termination visit
    Safety Issue?: No

Inclusion Criteria:

• Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e.
• inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
• At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

• Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
• Primary hypoactive sexual desire.
• Spinal cord injury
• History of surgical prostatectomy (transurethral interventions not excluded).
• Unstable angina pectoris.
• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
• Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate
• >100 BPM).

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00665054

Study ID Number: 11382

ClinicalTrials.gov Identifier: NCT00665054

Health Authority: Turkey: Ethics Committee

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