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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
297
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
Contains chlomipramine HCl 15mg.
Inje University Ilsan Paik Hospital
Goyang-si, South Korea
RECRUITINGNational Health Insurance Service Ilsan Hospital
Goyang-si, South Korea
RECRUITINGPusan National University Hospital
The fold change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time frame: From 4 weeks to 8 weeks after dosing
The % change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time frame: From 4 weeks to 8 weeks after dosing
The mean change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time frame: From 4 weeks to 8 weeks after dosing
The response rate
PEP (Premature Ejaculation Profile) questionnaire
Time frame: At 8 weeks after dosing
Global impression reported by patient
PGIG (Patient Global Impression of Change in Premature Ejaculation)
Time frame: At 8 weeks after dosing
Administration time of study drug
The time when a patient takes study drug before sexual attempt
Time frame: for 8 weeks
Number of patients with adverse events
It will be assessed by CTCAE v4.03
Time frame: for 8 weeks
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Placebo tablet of CDFR0812.
Placebo tablet of Condencia
Pusan, South Korea
Catholic Medical Center Seoul St. Mary's Hospital
Seoul, South Korea
RECRUITINGEwha Womans University Medical Center
Seoul, South Korea
RECRUITINGKorea University Guro Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGCatholic university of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si, South Korea
NOT_YET_RECRUITING