A Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a traumatic spinal cord injury

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Rehabilitation Research Center
• Treatments: Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

1. 18-65 years old, had ED more than 6 months

2. Traumatic spinal cord injury was the sole cause of ED

3. Patients had been in a heterosexual relationship for at least 1 month

4. Documented written informed consent.

Exclusion Criteria:

1. Presence of symptomatic active urinary tract infection, indwelling urethral catheter.

2. Patients who have used any kind of PDE-5i prior to the study

3. Other conditions that may cause ED such as history of radical prostatectomy, diabetes mellitus, anatomic penile abnormality and primary hypoactive sexual desire

4. History of symptomatic uncontrolled autonomic dysreflexia; postural hypotension

5. Cardiovascular abnormality such as unstable angina pectoris, myocardial infarction or stroke, electrocardiographic ischemia or life-threatening arrhythmia, resting systolic blood pressure>170 or <90 mmHg, diastolic pressure >110mmHg

6. Retinitis pigmentosa

7. Patients who currently were using any of the following medications: nitrates, nitric oxide donors, androgen or antiandrogen, anticoagulants, trazodone, erythromycin, azole antifungals, other contraindicative medications in package insert

8. Other contraindications in package insert