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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00725790
• Date of registration: 28/07/2008
• Primary sponsor: China Rehabilitation Research Center
• Public title: A Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury SCI
• Scientific title: Multi-Centre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
• Date of first enrolment: August 2008
• Target sample size: 350
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00725790
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Yan-He Ju, Dr.

• Name: Li-Min Liao, Dr.

• Name: Li-Min Liao, Dr.
• Affiliation: China Rehabilitation Research Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Intervention(s)

Drug: Placebo

Drug: Vardenafil

Primary Outcome(s)

EF domain score of IIEF [Time Frame: week 12]

Secondary Outcome(s)

IIEF/SEP/GAQ [Time Frame: at week 4, week 8, week 12]

Secondary ID(s)

SCI-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors