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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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

Detailed Summary:

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.


Sponsor: CTC Bio, Inc.

Current Primary Outcome: The fold change of IELT [ Time Frame: From 4 weeks to 8 weeks after dosing ]

IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The % change of IELT [ Time Frame: From 4 weeks to 8 weeks after dosing ]
    IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
  • The mean change of IELT [ Time Frame: From 4 weeks to 8 weeks after dosing ]
    IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
  • The response rate [ Time Frame: At 8 weeks after dosing ]
    PEP (Premature Ejaculation Profile) questionnaire
  • Global impression reported by patient [ Time Frame: At 8 weeks after dosing ]
    PGIG (Patient Global Impression of Change in Premature Ejaculation)
  • Administration time of study drug [ Time Frame: for 8 weeks ]
    The time when a patient takes study drug before sexual attempt
  • Number of patients with adverse events [ Time Frame: for 8 weeks ]
    It will be assessed by CTCAE v4.03


Original Secondary Outcome: Same as current

Information By: CTC Bio, Inc.

Dates:
Date Received: October 6, 2015
Date Started: November 2015
Date Completion: June 2016
Last Updated: December 16, 2015
Last Verified: December 2015