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

Lawson Health Research Institute

Status and phase

Completed

Phase 4

Conditions

Impotence

Treatments

Drug: Viagra

Study type

Interventional

Funder types

Other

Identifiers

NCT00199563

R-04-402 (Other Identifier)

Ethics Review: 10331

Details and patient eligibility

About

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)

Full 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.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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