Clinical trial NCT02571101: A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
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 Clomipramine HCl 15mg in Male Patients Diagnosed With Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Premature Ejaculation
Keywords: Clomipramine
Premature ejaculation
CDFR0812
Sildenafil
Lead sponsor: CTC Bio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2015-10-08
Enrollment: 297
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The fold change of IELT
timeFrame: From 4 weeks to 8 weeks after dosing
Secondary outcomes:
measure: The % change of IELT
timeFrame: From 4 weeks to 8 weeks after dosing
measure: The mean change of IELT
timeFrame: From 4 weeks to 8 weeks after dosing
measure: The response rate
timeFrame: At 8 weeks after dosing
measure: Global impression reported by patient
timeFrame: At 8 weeks after dosing
measure: Administration time of study drug
timeFrame: for 8 weeks
measure: Number of patients with adverse events
timeFrame: for 8 weeks
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic Medical Center Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Uijeongbu-si
country: Korea, Republic of
facility: Catholic university of Korea Uijeongbu St.Mary's Hospital
Study officials:
affiliation: Catholic Medical Center Seoul St. Mary's Hospital
name: Hwan-Seok Choi, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic Medical Center Seoul St. Mary's Hospital
name: Sae Woong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: