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

Sponsor
China Rehabilitation Research Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00725790
Collaborator
(none)
350
1
2
13
26.9

Study Details

Study Description

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 cord injury

Condition or Disease Intervention/Treatment Phase
Phase 4

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 approximately 52% of males aged 40-70 experience some degree of ED. Prevalence has been shown to increase with age, with an estimated 40% of the responders experiencing ED at age 40, whereas, 67% had difficulties by age 75.

Considerable advances have been made since the NIH Consensus statement that defined ED as the persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance. However, one thing remains the same, sexuality continues to be a driving force in our society today. Many men with erectile dysfunction suffer from issues of self esteem, self worth, the creation and maintenance of interpersonal relationships and in general, wrestle with an overall altered sense of wellbeing. Damage to personal relationships can ensue; and the anger, depression, and anxiety engendered spill over into all aspects of life.

VIAGRA(sildenafil), administered as a flexible-dose regimen, has demonstrated to be an effective and well-tolerated treatment for ED in spinal cord injury sufferers.This is a 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Aug 1, 2008
Anticipated Primary Completion Date :
Aug 1, 2009
Anticipated Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Vardenafil treatment group

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.

Placebo Comparator: B

Placebo treatment group

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.

Outcome Measures

Primary Outcome Measures

  1. EF domain score of IIEF [week 12]

Secondary Outcome Measures

  1. IIEF/SEP/GAQ [at week 4, week 8, week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Boai Hospital Affiliated to China Rehabilitation Research Center Beijing Beijing China 100077

Sponsors and Collaborators

  • China Rehabilitation Research Center

Investigators

  • Principal Investigator: Li-Min Liao, Dr., China Rehabilitation Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00725790
Other Study ID Numbers:
  • SCI-01
First Posted:
Jul 30, 2008
Last Update Posted:
Jul 30, 2008
Last Verified:
Jul 1, 2008

Study Results

No Results Posted as of Jul 30, 2008