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

2014-07-24 14:27:23 | BioPortfolio

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 characterisics predict for sildenafil erectile response and flow-mediated dilataiton (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Conditions

Impotence

Intervention

Viagra (drug) treatment of erectile dysfunction

Location

St. Joseph's Health Care London/Urology Clinic
London
Ontario
Canada
N6A 4V2

Status

Recruiting

Source

Lawson Health Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:27:23-0400

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Medical and Biotech [MESH] Definitions

Inability to achieve and maintain an erection (ERECTILE DYSFUNCTION) due to defects in the arterial blood flow to the PENIS, defect in venous occlusive function allowing blood drainage (leakage) from the erectile tissue (corpus cavernosum penis), or both.

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