CTRI/2010/091/001119已完成3 期
A randomized, double blind, placebo controlled, multicentric study to assess the efficacy and safety of Udenafil tablets in patients suffering from erectile dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- The change in the Erectile function domain of IIEF questionnaire
研究概览
简要总结
This study is a randomized, double blind, placebo controlled, multicentric study comparing the safety and efficacy of Udenafil 100 mg tablets and matching placebo given 30 minutes to 1 hour before anticipated sexual intercourse each for 8 weeks; in 120 patients with erectile dysfunction that will be conducted in five centers in India. The primary outcome measures will be the change in the Erectile function domain of IIEF questionnaire..
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male patients of 18 to 60 years of age 2.Stable, monogamous heterosexual relationship 3.Established diagnosis of erectile dysfunction (ED) 4.Informed consent of the patient.
排除标准
- •1.Total erectile failure or any other sexual disorder2.Hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie?s disease or penile trauma3.History of major psychiatric disorder4.History of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease5.History of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery6.Patients with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders7.History of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION)8.History of disorders that may cause priapism9.Any concomitant treatment which is not permissible10.Known hypersensitivity to PDE 5 inhibitors 11.Any other serious concurrent illness or malignancy12.Continuing history of alcohol and / or drug abuse13.Recent participation in another clinical trial.
结局指标
主要结局
The change in the Erectile function domain of IIEF questionnaire
时间窗: Baseline, 4 & 8 Weeks
次要结局
- (1)The change in the total score of IIEF questionnaire((2)Patient?s global impression of change)
研究者
研究点 (6)
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