A Prospective, Randomized, Double-blinded, Active-control, 3-Treatment Arm, Parallel, Multi-center, Phase 2 Trial to Evaluate Safety and Efficacy With CDFR0812-15/25mg and CDFR0812-15/50mg Compared to Clomipramine HCl 15mg in Male Patients Diagnosed With Premature Ejaculation
试验速览
- 阶段
- 2 期
- 入组人数
- 297
- 试验地点
- 9
- 主要终点
- The fold change of IELT
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of on-demand therapy with CDFR0812-15/25mg and CDFR0812-15/50mg compared to on-demand therapy with single-drug administration of Clomipramine HCl 15mg in Korean Male Patients Diagnosed with Premature Ejaculation
详细描述
Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent inhibitor of serotonin and norepinephrine reuptake. Clomipramine may be used in a variety of indications. Condencia Tab contains low dose of 15mg of clomipramine HCl as an active ingredient, which is newly approved to market for the treatment of premature ejaculation. This study is a prospective, randomized, double-blinded, active-control, 3-treatment arm, parallel, multi-center clinical trial. Approximately a total of 297 male patients diagnosed with premature ejaculation will be enrolled and randomized into 3 groups (99 subjects per a group).
The efficacy of oral administration of Clomipramine HCl will be investigated closely compared to the effects after oral administration of CDFR0812-15/25mg and CDFR0812-15/50mg.
The secondary object is to investigate general safety of oral administration of CDFR0812-15/25mg and CDFR0812-15/50mg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Korean male aged between 19 and 65
- •Both patient and his partner given their informed and written consents
- •Patient who has persisted for at least 6 months and is willing to retain the relationship during this study
- •Patient diagnosed with premature ejaculation according to DSM-V
- •Patient whose score in PEDT (Korean version) is 11 and more
- •Patient who are willing to try 4 and more intercourse attempts for Run-in period and he has experienced 75%-100% of the IELT within one minute or less of vaginal penetration
- •Patient whose personal distress in PEP is 'moderate' and over.
- •Patient who is willing to participate in the study by the end and are cooperative (trying 4 and more intercourse attempts between each visit and able to postpone scheduled elective surgery)
- •Patient who is willing to complete a patient diary and questionnaires
排除标准
- •Patient who has a medical history including neurological disorders, infectious diseases, damage, surgery or medication history and that is judged to be related to premature ejaculation
- •Patient who has participated into other trials within 90 days before this study
- •Patient who is in a unstable medical condition or has alcohol/drug abuse in recent 6 months
- •Patient whose female partner is less interested in sexual intercourse or has a sexual disorder
- •Patient whose female partner is pregnant
- •Patient whose female partner of childbearing age is not willing to use proper birth control
- •Patient whose IIEF-EF score is 25 and less
- •Medical history of convulsive diseases, mental diseases, E.C.T (Electroconvulsive shock Treatment), glaucoma
- •Patient who has taken concomitantly prohibited medicines before the study and who is not willing to stop the medications for appropriate wash-out period
研究组 & 干预措施
Test 1
Test 1 subjects will take one tablet of CDFR0812-15/25mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.
干预措施: CDFR0812-15/25mg (Drug)
Test 1
Test 1 subjects will take one tablet of CDFR0812-15/25mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.
干预措施: Condencia-Placebo (Drug)
Test 2
Test 2 subjects will take one tablet of CDFR0812-15/50mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.
干预措施: CDFR0812-15/50mg (Drug)
Test 2
Test 2 subjects will take one tablet of CDFR0812-15/50mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.
干预措施: Condencia-Placebo (Drug)
Comparator
Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.
干预措施: Condencia (Drug)
Comparator
Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.
干预措施: CDFR0812-Placebo (Drug)
结局指标
主要结局
The fold change of IELT
时间窗: From 4 weeks to 8 weeks after dosing
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
次要结局
- The % change of IELT(From 4 weeks to 8 weeks after dosing)
- The mean change of IELT(From 4 weeks to 8 weeks after dosing)
- The response rate(At 8 weeks after dosing)
- Global impression reported by patient(At 8 weeks after dosing)
- Administration time of study drug(for 8 weeks)
- Number of patients with adverse events(for 8 weeks)