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

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ClinicalTrials.gov Identifier: NCT02571101
Recruitment Status : Unknown
Verified December 2015 by CTC Bio, Inc..
Recruitment status was:  Recruiting
First Posted : October 8, 2015
Last Update Posted : December 17, 2015
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: CDFR0812-15/25mg Drug: CDFR0812-15/50mg Drug: Condencia Drug: CDFR0812-Placebo Drug: Condencia-Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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: CDFR0812-15/50mg
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.

Drug: Condencia-Placebo
Placebo tablet of Condencia

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.




Primary Outcome Measures :
  1. The fold change of IELT [ Time Frame: From 4 weeks to 8 weeks after dosing ]
    IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary


Secondary Outcome Measures :
  1. The % change of IELT [ Time Frame: From 4 weeks to 8 weeks after dosing ]
    IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary

  2. The mean change of IELT [ Time Frame: From 4 weeks to 8 weeks after dosing ]
    IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary

  3. The response rate [ Time Frame: At 8 weeks after dosing ]
    PEP (Premature Ejaculation Profile) questionnaire

  4. Global impression reported by patient [ Time Frame: At 8 weeks after dosing ]
    PGIG (Patient Global Impression of Change in Premature Ejaculation)

  5. Administration time of study drug [ Time Frame: for 8 weeks ]
    The time when a patient takes study drug before sexual attempt

  6. Number of patients with adverse events [ Time Frame: for 8 weeks ]
    It will be assessed by CTCAE v4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571101


Contacts
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Contact: Youngrang Lee 82-(0)70-4335-4759 yrlee@symyoo.com

Locations
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Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Goyang-si, Korea, Republic of
National Health Insurance Service Ilsan Hospital Recruiting
Goyang-si, Korea, Republic of
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Catholic Medical Center Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Ewha Womans University Medical Center Recruiting
Seoul, Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Catholic university of Korea Uijeongbu St.Mary's Hospital Not yet recruiting
Uijeongbu-si, Korea, Republic of
Sponsors and Collaborators
CTC Bio, Inc.
Symyoo
Investigators
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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

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Responsible Party: CTC Bio, Inc.
ClinicalTrials.gov Identifier: NCT02571101     History of Changes
Other Study ID Numbers: CTC-PED-CDFR0812_P2
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Keywords provided by CTC Bio, Inc.:
Clomipramine
Premature ejaculation
CDFR0812
Sildenafil
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Clomipramine
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs