Premature Ejaculation
Conditions
Keywords
Clomipramine, Premature ejaculation, CDFR0812, Sildenafil
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 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.
Interventions
DRUGCDFR0812-15/25mg
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
DRUGCDFR0812-15/50mg
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
DRUGCondencia
Contains chlomipramine HCl 15mg.
DRUGCDFR0812-Placebo
Placebo tablet of CDFR0812.
DRUGCondencia-Placebo
Placebo tablet of Condencia
Sponsors
Symyoo
CTC Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The fold change of IELT | From 4 weeks to 8 weeks after dosing | IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean change of IELT | From 4 weeks to 8 weeks after dosing | IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary |
| The response rate | At 8 weeks after dosing | PEP (Premature Ejaculation Profile) questionnaire |
| The % change of IELT | From 4 weeks to 8 weeks after dosing | IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary |
| Administration time of study drug | for 8 weeks | The time when a patient takes study drug before sexual attempt |
| Number of patients with adverse events | for 8 weeks | It will be assessed by CTCAE v4.03 |
| Global impression reported by patient | At 8 weeks after dosing | PGIG (Patient Global Impression of Change in Premature Ejaculation) |
Countries
South Korea
Contacts
Primary ContactYoungrang Lee
Outcome results
None listed