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

Erectile Dysfunction Clinical Trial

— SCI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00725790
• Other study ID #: SCI-01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 28, 2008
• Last updated: July 28, 2008
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2008
• Source: China Rehabilitation Research Center
• Contact: Li-Min Liao, Dr.
• Phone: +86 010 67563322
• Email: lmliao[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Spinal Cord Injuries

Intervention

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
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.

Locations

Country	Name	City	State
China	Beijing Boai Hospital Affiliated to China Rehabilitation Research Center	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Rehabilitation Research Center

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EF domain score of IIEF		week 12	No
Secondary	IIEF/SEP/GAQ		at week 4, week 8, week 12	No