Impotence Clinical Trial
Official title:
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.
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