NCT00199563

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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)

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 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.

Conditions

• Impotence

Interventions

Type	Name	Description
DRUG	Viagra	Sildenafil 100mg daily for 12 weeks

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-10-01
• Completion: 2007-12-01
• First posted: 2005-09-20
• Last updated: 2018-11-06

Locations

1 site across 1 country: Canada