The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
- 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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
active drug
Viagra 100 mg / daily for 12 weeks.
干预措施: Viagra (Drug)
Placebo
placebo/daily for 12 weeks
干预措施: Viagra (Drug)
结局指标
主要结局
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.
时间窗: 12 weeks
次要结局
- IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects(12 weeks)