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

Primary Purpose

Premature Ejaculation

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CDFR0812-15/25mg
CDFR0812-15/50mg
Condencia
CDFR0812-Placebo
Condencia-Placebo
Sponsored by
CTC Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring Clomipramine, Premature ejaculation, CDFR0812, Sildenafil

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Inje University Ilsan Paik HospitalRecruiting
  • National Health Insurance Service Ilsan HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Catholic Medical Center Seoul St. Mary's HospitalRecruiting
  • Ewha Womans University Medical CenterRecruiting
  • Korea University Guro HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Catholic university of Korea Uijeongbu St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Test 1

Test 2

Comparator

Arm Description

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 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 subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.

Outcomes

Primary Outcome Measures

The fold change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary

Secondary Outcome Measures

The % change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
The mean change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
The response rate
PEP (Premature Ejaculation Profile) questionnaire
Global impression reported by patient
PGIG (Patient Global Impression of Change in Premature Ejaculation)
Administration time of study drug
The time when a patient takes study drug before sexual attempt
Number of patients with adverse events
It will be assessed by CTCAE v4.03

Full Information

First Posted
October 6, 2015
Last Updated
December 16, 2015
Sponsor
CTC Bio, Inc.
Collaborators
Symyoo
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1. Study Identification

Unique Protocol Identification Number
NCT02571101
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTC Bio, Inc.
Collaborators
Symyoo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Clomipramine, Premature ejaculation, CDFR0812, Sildenafil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
297 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Test 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparator
Arm Type
Placebo Comparator
Arm Description
Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
CDFR0812-15/25mg
Intervention Description
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
Intervention Type
Drug
Intervention Name(s)
CDFR0812-15/50mg
Intervention Description
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
Intervention Type
Drug
Intervention Name(s)
Condencia
Intervention Description
Contains chlomipramine HCl 15mg.
Intervention Type
Drug
Intervention Name(s)
CDFR0812-Placebo
Intervention Description
Placebo tablet of CDFR0812.
Intervention Type
Drug
Intervention Name(s)
Condencia-Placebo
Intervention Description
Placebo tablet of Condencia
Primary Outcome Measure Information:
Title
The fold change of IELT
Description
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time Frame
From 4 weeks to 8 weeks after dosing
Secondary Outcome Measure Information:
Title
The % change of IELT
Description
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time Frame
From 4 weeks to 8 weeks after dosing
Title
The mean change of IELT
Description
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time Frame
From 4 weeks to 8 weeks after dosing
Title
The response rate
Description
PEP (Premature Ejaculation Profile) questionnaire
Time Frame
At 8 weeks after dosing
Title
Global impression reported by patient
Description
PGIG (Patient Global Impression of Change in Premature Ejaculation)
Time Frame
At 8 weeks after dosing
Title
Administration time of study drug
Description
The time when a patient takes study drug before sexual attempt
Time Frame
for 8 weeks
Title
Number of patients with adverse events
Description
It will be assessed by CTCAE v4.03
Time Frame
for 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngrang Lee
Phone
82-(0)70-4335-4759
Email
yrlee@symyoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwan-Seok Choi, M.D, Ph.D.
Organizational Affiliation
Catholic Medical Center Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sae Woong Kim, M.D., Ph.D.
Organizational Affiliation
Catholic Medical Center Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Catholic Medical Center Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Catholic university of Korea Uijeongbu St.Mary's Hospital
City
Uijeongbu-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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