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

Study Description

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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
Erectile Dysfunction	Drug: Vardenafil; Drug: Placebo	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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	August 2008
Estimated Primary Completion Date :	August 2009
Estimated Study Completion Date :	September 2009

Arms and Interventions

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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

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Primary Outcome Measures :

1. EF domain score of IIEF [ Time Frame: week 12 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes 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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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:	Professor Li-Min Liao, China Rehabilitation Research Center
ClinicalTrials.gov Identifier:	NCT00725790 History of Changes
Other Study ID Numbers:	SCI-01
First Posted:	July 30, 2008
Last Update Posted:	July 30, 2008
Last Verified:	July 2008

Keywords provided by China Rehabilitation Research Center:

Erectile Dysfunction; Spinal Cord Injury

Additional relevant MeSH terms:

Spinal Cord Injuries; Erectile Dysfunction; 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