Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
Lead Sponsor:
China Rehabilitation Research Center
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
According to the Massachusetts Male Aging Study, erectile dysfunction (ED) is estimated as affecting approximately 30 million American men and 100 million men worldwide. The study also reported that a...
Eligibility Criteria
Inclusion
- 18-65 years old, had ED more than 6 months
- Traumatic spinal cord injury was the sole cause of ED
- Patients had been in a heterosexual relationship for at least 1 month
- Documented written informed consent.
Exclusion
- Presence of symptomatic active urinary tract infection, indwelling urethral catheter.
- Patients who have used any kind of PDE-5i prior to the study
- Other conditions that may cause ED such as history of radical prostatectomy, diabetes mellitus, anatomic penile abnormality and primary hypoactive sexual desire
- History of symptomatic uncontrolled autonomic dysreflexia; postural hypotension
- 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
- Retinitis pigmentosa
- 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
- Other contraindications in package insert
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00725790
Start Date
August 1 2008
End Date
September 1 2009
Last Update
July 30 2008
Active Locations (1)
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1
Beijing Boai Hospital Affiliated to China Rehabilitation Research Center
Beijing, Beijing Municipality, China, 100077