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

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: Vardenafil (Levitra, BAY38-9456); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654680

10473

Details and patient eligibility

About

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

Enrollment: 418 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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418 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Vardenafil (Levitra, BAY38-9456)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo