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Sponsored by: |
China Rehabilitation Research Center |
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Information provided by: | China Rehabilitation Research Center |
ClinicalTrials.gov Identifier: | NCT00725790 |
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 |
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 |
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 |
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A: Experimental
Vardenafil treatment group
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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
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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. |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yan-He Ju, Dr. | +86 010 87458636 | jyhgjj@163.com |
Contact: Li-Min Liao, Dr. | +86 010 67563322 ext 3702 | lmliao@263.net |
China | |
Beijing Boai Hospital Affiliated to China Rehabilitation Research Center | |
Beijing, China, 100077 |
Principal Investigator: | Li-Min Liao, Dr. | China Rehabilitation Research Center |
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 |
Erectile Dysfunction Spinal Cord Injury |
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 |
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 |