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

Erectile Dysfunction research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Erectile Dysfunction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Vardenafil10 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.

Drug:Placebo10 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AVardenafil treatment group

BPlacebo treatment group

Study Status

Unknown status

Start Date: August 2008

Completed Date: September 2009

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: EF domain score of IIEF

Secondary Outcome: IIEF/SEP/GAQ

Study sponsors, principal investigator, and references

Principal Investigator: Li-Min Liao, Dr.

Lead Sponsor: China Rehabilitation Research Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00725790

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.

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