Study Evaluating the Efficacy and Safety of Flexible-Dose 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); 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 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sexual Encounter Profile Question 2
Secondary outcome: Sexual Encounter Profile Question 3Internation Index of Erectile Function-Erectile Function domain Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men ≥18 years of age, with 6 months or longer diagnosis of ED as defined by NIH
Consensus statement,
- History of unresponsiveness to sildenafil
- 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 US Product Information
Locations and Contacts
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: June 2003
Ending date: February 2004
Last updated: April 9, 2008
|
