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

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

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

Study Overview

• Status: Unknown
• Conditions: Premature Ejaculation
• Intervention / Treatment: Drug: CDFR0812-15/25mg; Drug: Condencia-Placebo; Drug: CDFR0812-15/50mg; Drug: Condencia; Drug: CDFR0812-Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 297
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Youngrang Lee; Phone Number: 82-(0)70-4335-4759; Email: yrlee@symyoo.com

Study Locations

• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
  • Goyang-si, Korea, Republic of
    • Recruiting
    • National Health Insurance Service Ilsan Hospital
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Catholic Medical Center Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha womans university medical center
  • Uijeongbu-si, Korea, Republic of
    • Not yet recruiting
    • Catholic university of Korea Uijeongbu St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1; 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; Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.; Drug: Condencia-Placebo; Placebo tablet of Condencia
Experimental: Test 2; 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: Condencia-Placebo; Placebo tablet of Condencia; Drug: CDFR0812-15/50mg; Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
Placebo Comparator: Comparator; 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; Contains chlomipramine HCl 15mg.; Drug: CDFR0812-Placebo; Placebo tablet of CDFR0812.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CTC Bio, Inc.
• Collaborators: Symyoo
• Investigators: Principal Investigator: Hwan-Seok Choi, M.D, Ph.D., Catholic Medical Center Seoul St. Mary's Hospital; Principal Investigator: Sae Woong Kim, M.D., Ph.D., Catholic Medical Center Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Sildenafil; Premature ejaculation; Clomipramine; CDFR0812
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: CTC-PED-CDFR0812_P2