Official Title: “Open-Label, Multi-Centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction”

Study to investigate the efficacy and safety of Vardenafil

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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 aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 5mg, 10mg or 20mg taken 1 hours before sexual intercourse

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• International Index of Erectile Function - Erectile Function Domain
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Sexual Encounter Profile Question 2 and 3
  • Time Frame: 12 weeks
    Safety Issue?: No
• Global Assessment Question
  • Time Frame: 12 weeks
    Safety Issue?: No
• Other diary based variables
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Men ≥ 18 years of age, with
• ED 6 months or longer
• 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
• 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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00681772

Study ID Number: 100541

ClinicalTrials.gov Identifier: NCT00681772

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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