The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
active drug
Viagra 100 mg / daily for 12 weeks.
Intervention: Viagra (Drug)
Placebo
placebo/daily for 12 weeks
Intervention: Viagra (Drug)
Outcomes
Primary Outcomes
Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo.
Time Frame: 12 weeks
Secondary Outcomes
- IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects(12 weeks)