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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

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 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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Sildenafil Citrate

Criteria

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