Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury
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
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury
Clinical Details
Official title: A Rand, db, Parallel-Group, Plac-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: International Index of Erectile Function-Erectile Function domain
Secondary outcome: Sexual Encounter Profile Question 2Sexual Encounter Profile Question 3 Other diary based variables Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Males ≥18 years with ED solely as a result of traumatic SCI for ≥6 months with
demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
- Stable heterosexual relationship for at least 1 month.
Exclusion Criteria:
- Subjects with unstable medical or psychiatric conditions or using prohibited
concomitant medications
- 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 US Product Information or Summary of
Product Characteristics
Locations and Contacts
Additional Information
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Starting date: October 2002
Ending date: January 2004
Last updated: April 4, 2008
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