Premature Ejaculation Clinical Trial
Official title:
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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