Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Vardenafil (Levitra, BAY38-9456); Drug: Placebo

• Registration Number: NCT00654680
• Lead Sponsor: Bayer

Brief Summary

Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 418

Inclusion Criteria

• Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Vardenafil (Levitra, BAY38-9456)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function-Erectile Function domain	12 weeks

Secondary Outcome Measures

Name	Time	Method
Sexual Encounter Profile Question 2	12 weeks
Sexual Encounter Profile Question 3	12 weeks
Other diary based variables	12 weeks
Safety and tolerability	12 weeks