Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction...
Date First Received: April 17, 2008
Last Updated: June 5, 2009
Verified by: Bayer, June 2009
Clinical Trial Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed
Estimated Enrollment: 30000
Brief Summary
Official Title: “REALISE Levitra® - Real Life Safety and Efficacy of Levitra”
Condition Keyword(s):
Intervention(s):
Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Levitra (Vardenafil, BAY38-9456)
- Treatment according to US PI
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Arm 1
Outcome Measures for this Clinical Trial
Primary Measures
- Improvement of Erectile Disfunction
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
- Onset of Drug Effect
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
- Second successful intercourse
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
Secondary Measures
- General Safety Parameters
- Time Frame: 8 weeks
Safety Issue?: Yes
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US
- National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment
Exclusion Criteria:
- Exclusion according to US PI
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
Clinical Trial Sponsor Information
Lead Sponsor: Bayer
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663598
Study ID Number: 100477
ClinicalTrials.gov Identifier: NCT00663598
Health Authority: United States: Food and Drug Administration
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