A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
- Conditions
- Premature Ejaculation
- Interventions
- Drug: CDFR0812-15/25mgDrug: CDFR0812-15/50mgDrug: CondenciaDrug: Condencia-PlaceboDrug: CDFR0812-Placebo
- Registration Number
- NCT02571101
- Lead Sponsor
- CTC Bio, Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 297
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test 1 CDFR0812-15/25mg 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. Test 1 Condencia-Placebo 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. Test 2 CDFR0812-15/50mg 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. Test 2 Condencia-Placebo 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. Comparator Condencia Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks. Comparator CDFR0812-Placebo Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Global impression reported by patient At 8 weeks after dosing PGIG (Patient Global Impression of Change in Premature Ejaculation)
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
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
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
Trial Locations
- Locations (9)
Catholic Medical Center Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang-si, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Ewha Womans University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Catholic university of Korea Uijeongbu St.Mary's Hospital
🇰🇷Uijeongbu-si, Korea, Republic of