A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Symyoo
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Fold cahnges of Intraviginal ejaculation latency time (IELT)
研究概览
简要总结
The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.
详细描述
This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent for subjects and partdners
- •Men 20-65
- •stable monogamous relation at least for 6 mn
- •PEDT more than 9
- •at least 6 Mn of premature ejaculation Hx
- •IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period
排除标准
- •Hx of medical or psychiartric illness
- •erectile dysfunction (<21 IIEF EF domain score) or other forms of sexual dysfunction
- •Partner sexual dysfunction
- •known hypersensitivity to clomipramine and contraindications for clomipramine
研究组 & 干预措施
PED 0
placebo
干预措施: Clomipramine (Drug)
PED 1
PED-1 (clomipramine 15mg)
干预措施: Clomipramine (Drug)
PED-2
PED-2 (Clomipramine 30mg)
干预措施: Clomipramine (Drug)
结局指标
主要结局
Fold cahnges of Intraviginal ejaculation latency time (IELT)
时间窗: 4 weeks
次要结局
- Drug coitus interval time(4 week)