Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels
- 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 compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction
- To assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use
- To assess if microalbuminuria predicts flow-mediated dilation (FMD) response
- To measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study|
- Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Active Comparator: active drug
Viagra 100 mg / daily for 12 weeks.
Sildenafil 100mg daily for 12 weeks
Other Name: Sildenafil
Placebo Comparator: Placebo
placebo/daily for 12 weeks
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 blinded. Subjects will be followed by IIEF, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry.
Study time-points are at baseline, 6 and 12 weeks.
Study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.
|St. Joseph's Health Care London/Urology Clinic|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Gerald B Brock, MD||Lawson Health Research Institute/St. Joseph's Health Care London|