NCT01798667Unknown2 期
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- average IELT change
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.
The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged with premature ejaculation for more than 6 months.
- •PEDT score ≥ 11
排除标准
- •IIEF-EF domain ≤ 21
- •Serum Creatinine ≥ 2.5 mg/dl
- •AST, ALT > 3*Upper limit of normal
- •Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg)
- •Subjects with chronic depression, psychiatric or schizophrenia,
- •Subjects with alcohol, drug or substance abuse
研究组 & 干预措施
Placebo
Placebo Comparator
PO administration
干预措施: Placebo (Drug)
DA-8031 dose 1
Experimental
PO administration
干预措施: DA-8031 (Drug)
DA-8031 dose 2
Experimental
PO administration
干预措施: DA-8031 (Drug)
DA-8031 dose 3
Experimental
PO administration
干预措施: DA-8031 (Drug)
结局指标
主要结局
average IELT change
时间窗: From 0 week(baseline) to 8 week(end of treatment)
次要结局
- PEP, PGI(8 weeks)
研究者
研究点 (1)
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