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

PHASE4UnknownINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

September 30, 2009

Conditions
Erectile Dysfunction
Interventions
DRUG

Vardenafil

"10 mg vardenafil on demand treatment for first 4 weeks.~A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period.~A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period."

DRUG

Placebo

"10 mg placebo on demand treatment for first 4 weeks.~A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period.~A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period."

Trial Locations (1)

100077

Beijing Boai Hospital Affiliated to China Rehabilitation Research Center, Beijing

All Listed Sponsors
lead

China Rehabilitation Research Center

OTHER_GOV