A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation

  • STATUS
    Not Recruiting
  • participants needed
    297
  • sponsor
    CTC Bio, Inc.
Updated on 21 January 2021
elective surgery
clomipramine

Summary

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

Description

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.

Details
Treatment CDFR0812-15/25mg, CDFR0812-15/50mg, Condencia, CDFR0812-Placebo, Condencia-Placebo
Clinical Study IdentifierNCT02571101
SponsorCTC Bio, Inc.
Last Modified on21 January 2021

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