Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
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); Placebo (Drug)
Phase: Phase 3
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: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sexual Encounter Profile question 2 (SEP 2)
Secondary outcome: Sexual Encounter Profile question 3 (SEP 3)International Index of Erectile Function (IIEF) - EF (Erectile Function) domain Safety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Heterosexual males
- >= 18 years old with ED for more than six months
- Subjects also needed a positive first-time response to a single dose of 10mg
vardenafil to be eligible for randomisation
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: June 2003
Ending date: January 2004
Last updated: April 24, 2008
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