Status:
COMPLETED
Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Impotence
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
* To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns. * To determine if chronic sildenafil use...
Detailed Description
60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly ...
Eligibility Criteria
Inclusion
- Age \> 18 years of age
- Type 2 diabetes \> 6 months in duration. Men using oral hypoglycemic agents and /or insulin will be permitted into the trial.
- Stable hetero- sexual relationship for \> 6 months
- IIEF score at baseline \<21·
- Agrees to sign informed consent
Exclusion
- Known hypersensitivity to sildenafil
- Use of nitrates
- Use of anti-coagulants
- History of significant heart disease, +/or myocardial infarction within last 6 months
- Unable to understand or unwilling to sign informed consent
- Concomitant use of erectogenic agent during study
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00199563
Start Date
August 1 2004
End Date
December 1 2007
Last Update
November 6 2018
Active Locations (1)
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1
St. Joseph's Health Care London/Urology Clinic
London, Ontario, Canada, N6A 4V2