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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: CDFR0812-15/25mg
* Drug: CDFR0812-15/50mg
* Drug: Condencia
* Drug: CDFR0812-Placebo
* Drug: Condencia-Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Korean male aged between 19 and 65 Both patient and his partner given their informed and written consents Patient who has persisted for at least 6 months and is willing to retain the relationship during this study Patient diagnosed with premature ejaculation according to DSM-V Patient whose score in PEDT (Korean version) is 11 and more Patient who are willing to try 4 and more intercourse attempts for Run-in period and he has experienced 75%-100% of the IELT within one minute or less of vaginal penetration Patient whose personal distress in PEP is 'moderate' and over. Patient who is willing to participate in the study by the end and are cooperative (trying 4 and more intercourse attempts between each visit and able to postpone scheduled elective surgery) Patient who is willing to complete a patient diary and questionnaires Exclusion Criteria: Patient who has a medical history including neurological disorders, infectious diseases, damage, surgery or medication history and that is judged to be related to premature ejaculation Patient who has participated into other trials within 90 days before this study Patient who is in a unstable medical condition or has alcohol/drug abuse in recent 6 months Patient whose female partner is less interested in sexual intercourse or has a sexual disorder Patient whose female partner is pregnant Patient whose female partner of childbearing age is not willing to use proper birth control Patient whose IIEF-EF score is 25 and less Medical history of convulsive diseases, mental diseases, E.C.T (Electroconvulsive shock Treatment), glaucoma Patient who has taken concomitantly prohibited medicines before the study and who is not willing to stop the medications for appropriate wash-out period

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test 1<br>Test 1 subjects will take one tablet of CDFR0812-15/25mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks. | Drug: CDFR0812-15/25mg<br>* Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.<br>Drug: Condencia-Placebo<br>* Placebo tablet of Condencia<br>|
| Experimental: Test 2<br>Test 2 subjects will take one tablet of CDFR0812-15/50mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks. | Drug: CDFR0812-15/50mg<br>* Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.<br>Drug: Condencia-Placebo<br>* Placebo tablet of Condencia<br>|
| Placebo Comparator: Comparator<br>Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks. | Drug: Condencia<br>* Contains chlomipramine HCl 15mg.<br>Drug: CDFR0812-Placebo<br>* Placebo tablet of CDFR0812.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fold change of IELT | IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary | From 4 weeks to 8 weeks after dosing | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clomipramine, Premature ejaculation, CDFR0812, Sildenafil