NCT00654017已完成4 期
Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Flexible, Titration Dose Administered on an As Needed Basis (PRN) to Evaluate the Efficacy and the Safety of Sildenafil for the Treatment of Erectile Dysfunction in Male Patients on Hemodialysis
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
研究概览
简要总结
The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Included patients had been in a stable relationship with a female partner for at least 6 months
- •A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".
排除标准
- •Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
- •Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
- •Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
- •Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
sildenafil
Active Comparator
干预措施: sildenafil (Drug)
结局指标
主要结局
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
时间窗: Baseline and Week 10
次要结局
- responses to questions of the IIEF(Baseline and Week 10)
- response to Partner's Satisfaction Questionnaire (optional)(Week 10)
- response to Question 1 of the Global Efficacy Assessment Question(Week 10)
- rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful)(Baseline to Week 10)
- total Score of Quality of Life and erectile dysfunction questionnaire(Baseline and Week 10)
- monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate(Baseline, and Weeks 2, 4, 6, and 10)
研究者
研究点 (1)
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