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

NCT00725790 | Unknown Phase 4

• 1 other identifier: SCI-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• EF domain score of IIEF

  week 12

Secondary Outcomes (1)

• IIEF/SEP/GAQ

  at week 4, week 8, week 12

Study Arms (2)

A

EXPERIMENTAL

Vardenafil treatment group

Drug: Vardenafil

B

PLACEBO COMPARATOR

Placebo treatment group

Drug: Placebo

Interventions

Vardenafil DRUG

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.

A

Placebo DRUG

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.

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Rehabilitation Research Center: lead

Study Sites (1)

Beijing Boai Hospital Affiliated to China Rehabilitation Research Center

Beijing, Beijing Municipality, 100077, China

Location

Related 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. doi: 10.1016/s0022-5347(17)34871-1.

  PMID: 8254833 BACKGROUND

• 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.

  PMID: 9727821 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction; Spinal Cord Injuries

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Li-Min Liao, Dr.

  China Rehabilitation Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Min Liao, Dr.

CONTACT

+86 010 67563322; lmliao@263.net

Yan-He Ju, Dr.

CONTACT

+86 010 87458636; jyhgjj@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

CN (1)