A Prospective, Randomized, Double-blinded, Active-control, 3-Treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of On-demand Therapy with CDFR0812-15/50mg Compared to On-demand Therapy with Single-drug Administration of Clomipramine HCl 15mg or Sildenafil citrate 50mg in Male Patients Diagnosed with Premature Ejaculation

CTC Bio0 个研究点目标入组 792 人开始时间: 待定最近更新: 2022年9月20日

适应症

试验速览

暂无简介。

•1) Subjects who voluntarily consented, after listing enough explanation for this study and investigational product.
•2) Informed consent for partner
•3) Men, over 19 years and under 65 years
•4) Diagnostic and Statistical Manual of Mental Disorders (DSM)-V defined Premature Ejaculation Medical History
•5) More than 11 points in the Korean version of the Premature Ejaculation Diagnostic Table (PEDT)
•6) 'Personal despondency' or 'Relative impediment' of PEP Questionnaire items is more than moderate
•7) Subjects who are communicative
•8) Subjects who is willing to complete the study diary card

•1) IIEF-EF domain score <=25
•2) Total testosterone less than 200 ng/dl (6.9 nmol/L)
•3) Subjects who has Major mental disorder(e.g., panic disorder, bipolar disorder, chronic depression, or schizophrenia)
•4) Subjects who has uncontrolled arrhythmia(e.g., attack tachycardia, sinus tachycardia)
•5) Subjects who has standing low blood pressure with confirmed
•6) High blood pressure that is not regulated despite treatment (Stabilizer SBP > 180mmHg or Stabilizer EBP > 110 mmHg measured during a screening visit)
•7) Subjects who has digestive system with expected to have drug absorption disorder
•8) Chronic liver disease or liver failure of severe disease (AST or ALT >3 x ULN)
•9) Subjects with hepatitis B and hepatitis C or HIV positive
•10) Known hypersensitivity to clomipramine, Sildenafil and contraindications for clomipramine, sildenafil

发起方

CTC Bio