Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
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
Study to investigate the efficacy and safety of Vardenafil
Clinical Details
Official title: Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Primary outcome: International Index of Erectile Function- Erectile Function domain
Secondary outcome: Global Assessment Questionnaire (GAQ)Safety and tolerability
Detailed description:
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 purpose was the
evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile
Dysfunction (ED).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men ≥ 18 years of age
- Erectile Dysfunction
Exclusion Criteria:
- 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
Locations and Contacts
Additional Information
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Starting date: September 2003
Ending date: June 2004
Last updated: April 18, 2008
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