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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by China Rehabilitation Research Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
China Rehabilitation Research Center
ClinicalTrials.gov Identifier:
NCT00725790
First received: July 28, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose
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 Intervention Phase
Erectile Dysfunction
 Drug: Vardenafil
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by China Rehabilitation Research Center:

Primary Outcome Measures:
  • EF domain score of IIEF [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IIEF/SEP/GAQ [ Time Frame: at week 4, week 8, week 12 ] [ Designated as safety issue: No ]
Estimated Enrollment: 350
Study Start Date: August 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725790

Contacts
Contact: Li-Min Liao, Dr. +86 010 67563322 ext 3702 lmliao@263.net
Contact: Yan-He Ju, Dr. +86 010 87458636 jyhgjj@163.com

Locations
China, Beijing
Beijing Boai Hospital Affiliated to China Rehabilitation Research Center Not yet recruiting
Beijing, Beijing, China, 100077
Contact: Yan-He Ju, Dr.    +86 010 87458636    jyhgjj@163.com   
Principal Investigator: Li-Min Liao, Dr.         
Sponsors and Collaborators
China Rehabilitation Research Center
Investigators
Principal Investigator: Li-Min Liao, Dr. China Rehabilitation Research Center
  More Information

Publications:

Responsible Party: Professor Li-Min Liao, China Rehabilitation Research Center
ClinicalTrials.gov Identifier: NCT00725790     History of Changes
Other Study ID Numbers: SCI-01 
Study First Received: July 28, 2008
Last Updated: July 28, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by China Rehabilitation Research Center:
Erectile Dysfunction
Spinal Cord Injury

Additional relevant MeSH terms:
Erectile Dysfunction
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Sexual Dysfunction, Physiological
Genital Diseases, Male
 Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 28, 2016