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

Sponsored by:	China Rehabilitation Research Center
Information provided by:	China Rehabilitation Research Center
ClinicalTrials.gov Identifier:	NCT00725790

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 IV

MedlinePlus related topics: Erectile Dysfunction Rehabilitation Spinal Cord Injuries

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Double Blind (Subject, Investigator), Parallel Assignment, Placebo Control, Randomized, Safety/Efficacy Study, 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

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
A: Experimental 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.
B: Placebo Comparator 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.

Arms

Assigned Interventions

A: Experimental

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.

B: Placebo Comparator

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
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-65 years old, had ED more than 6 months
Traumatic spinal cord injury was the sole cause of ED
Patients had been in a heterosexual relationship for at least 1 month
Documented written informed consent.

Exclusion Criteria:

Presence of symptomatic active urinary tract infection, indwelling urethral catheter.
Patients who have used any kind of PDE-5i prior to the study
Other conditions that may cause ED such as history of radical prostatectomy, diabetes mellitus, anatomic penile abnormality and primary hypoactive sexual desire
History of symptomatic uncontrolled autonomic dysreflexia; postural hypotension
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
Retinitis pigmentosa
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
Other contraindications in package insert

Contacts and Locations

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

Contacts

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

Locations

China
Beijing Boai Hospital Affiliated to China Rehabilitation Research Center
Beijing, China, 100077

Sponsors and Collaborators

China Rehabilitation Research Center

Investigators

Principal Investigator:

Li-Min Liao, Dr.

China Rehabilitation Research Center

More Information

Publications:

Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61.

Korenman SG. New insights into erectile dysfunction: a practical approach. Am J Med. 1998 Aug;105(2):135-44. Review.

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

Keywords provided by China Rehabilitation Research Center:

Erectile Dysfunction
Spinal Cord Injury

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Spinal Cord Diseases
Wounds and Injuries
Benzocaine
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System

Genital Diseases, Male
Spinal Cord Injuries
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Vardenafil
Mental Disorders
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Enzyme Inhibitors
Trauma, Nervous System

Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Spinal Cord Injuries
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Mental Disorders
Erectile Dysfunction

ClinicalTrials.gov processed this record on March 16, 2009