A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Symyoo
- 入组人数
- 159
- 试验地点
- 5
- 主要终点
- Intravaginal ejaculation latency time (IELT)(seconds)
研究概览
简要总结
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
详细描述
This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 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 partners
- •Men 20-65 ages
- •Stable monogamous relation at least for 6 mo
- •Premature Ejaculation Diagnosis Tool (PEDT) more than 9
- •At least 6 mo of premature ejaculation Hx
- •IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period
排除标准
- •History of medical or psychiatric illness
- •Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (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-1
PED-1 (Clomipramine 15 mg)
干预措施: Clomipramine (Drug)
placebo
干预措施: Clomipramine (Drug)
结局指标
主要结局
Intravaginal ejaculation latency time (IELT)(seconds)
时间窗: 12 weeks
次要结局
- Drug coitus interval time (hours)(12 weeks)