Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels

The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study

• 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)

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.

Inclusion Criteria:

• 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 Criteria:

• 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