Clinical trial NCT00725790: A Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Spinal Cord Injury
Lead sponsor: China Rehabilitation Research Center
Sponsor class: OTHER_GOV
First posted: 2008-07-30
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: EF domain score of IIEF
timeFrame: week 12
Secondary outcomes:
measure: IIEF/SEP/GAQ
timeFrame: at week 4, week 8, week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Boai Hospital Affiliated to China Rehabilitation Research Center
state: Beijing
Study officials:
affiliation: China Rehabilitation Research Center
name: Li-Min Liao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0022-5347(17)34871-1.
citation: Korenman SG. New insights into erectile dysfunction: a practical approach. Am J Med. 1998 Aug;105(2):135-44. doi: 10.1016/s0002-9343(98)00191-0.