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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)
Recruitment status was: Not yet recruiting
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Erectile Dysfunction | Drug: Vardenafil Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
- EF domain score of IIEF [ Time Frame: week 12 ]
- IIEF/SEP/GAQ [ Time Frame: at week 4, week 8, week 12 ]
| 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) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00725790
| Contact: Li-Min Liao, Dr. | +86 010 67563322 ext 3702 | lmliao@263.net | |
| Contact: Yan-He Ju, Dr. | +86 010 87458636 | jyhgjj@163.com |
| 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. | |
| 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 |
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 |
ClinicalTrials.gov processed this record on July 19, 2017