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

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02571101
• Other study ID #: CTC-PED-CDFR0812_P2
• Status: Recruiting
• Phase: Phase 2
• First received: October 6, 2015
• Last updated: December 16, 2015
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: CTC Bio, Inc.
• Contact: Youngrang Lee
• Phone: 82-(0)70-4335-4759
• Email: yrlee[@]symyoo.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 297
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• CDFR0812-15/25mg
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
• CDFR0812-15/50mg
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
• Condencia
Contains chlomipramine HCl 15mg.
• CDFR0812-Placebo
Placebo tablet of CDFR0812.
• Condencia-Placebo
Placebo tablet of Condencia

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang-si
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Catholic Medical Center Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Catholic university of Korea Uijeongbu St.Mary's Hospital	Uijeongbu-si

Sponsors (2)

Lead Sponsor	Collaborator
CTC Bio, Inc.	Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The response rate	PEP (Premature Ejaculation Profile) questionnaire	At 8 weeks after dosing	No
Secondary	Global impression reported by patient	PGIG (Patient Global Impression of Change in Premature Ejaculation)	At 8 weeks after dosing	No
Secondary	Administration time of study drug	The time when a patient takes study drug before sexual attempt	for 8 weeks	No
Secondary	Number of patients with adverse events	It will be assessed by CTCAE v4.03	for 8 weeks	Yes