Evaluation of the Safety and Efficacy 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 to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: International Index of Erectile Function - Erectile Function Domain
Secondary outcome: Sexual Encounter Profile Question 2 and 3Global Assessment Question Other diary based variables 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 aim of this
study was to investigate safety, tolerability and efficacy of vardenafil following a flexible
dose treatment schedule in subjects with varying aetiology.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: March 2003
Ending date: November 2003
Last updated: May 20, 2008
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