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

NCT00725790 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2008-07-30

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

  • China Rehabilitation Research Center

    lead OTHER_GOV

Principal Investigators

  • Li-Min Liao, Dr. · China Rehabilitation Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00725790 on ClinicalTrials.gov