REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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)
Clinical Details
Official title: REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Improvement of Erectile DisfunctionOnset of Drug Effect Second successful intercourse
Secondary outcome: General Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: October 2003
Ending date: September 2004
Last updated: April 21, 2008
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