Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
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 Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen 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: Per-patient success rates based on Sexual Encounter Profile, Question 3
Secondary outcome: Per-subject success rates based on Sexual Encounter Profile, Question 2International Index of Erectile Function- Erectile Function domain score Global Assessment Question (GAQ) Safety and tolerability
Detailed description:
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil
therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile
dysfunction subjects of a broad etiology when dosed 8 (±2) hours prior to sexual intercourse.
In addition it should have been determined, if subjects with ED from a broad etiology can
tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(±2) hours prior to sexual
intercourse.
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.
Locations and Contacts
Additional Information
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Starting date: December 2003
Ending date: August 2004
Last updated: May 20, 2008
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