Official Title: “A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen 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

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (±2) hours prior to sexual intercourse.

In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(±2) hours prior to sexual intercourse.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 5mg, 10mg or 20mg taken 8 hours before sexual intercourse
• Drug: Placebo
  • matching placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Per-patient success rates based on Sexual Encounter Profile, Question 3
  • Time Frame: 10 weeks
    Safety Issue?: No

Secondary Measures

• Per-subject success rates based on Sexual Encounter Profile, Question 2
  • Time Frame: 10 weeks
    Safety Issue?: No
• International Index of Erectile Function- Erectile Function domain score
  • Time Frame: 10 weeks
    Safety Issue?: No
• Global Assessment Question (GAQ)
  • Time Frame: 10 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 10 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Men ≥ 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH
• Consensus statement,
• History of unresponsiveness to sildenafil
• Stable sexual relationship for > 6 month.

Exclusion Criteria:

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy.

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/NCT00682019

Study ID Number: 100493

ClinicalTrials.gov Identifier: NCT00682019

Health Authority: United States: Food and Drug Administration

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