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

Last updated: December 16, 2015
Sponsor: CTC Bio, Inc.
Overall Status: Trial Status Unknown

Phase

2

Condition

Premature Ejaculation

Treatment

N/A

Clinical Study ID

NCT02571101
CTC-PED-CDFR0812_P2
  • Ages 19-65
  • Male

Study 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

Eligibility Criteria

Inclusion

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 therelationship 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 andhe has experienced 75%-100% of the IELT within one minute or less of vaginalpenetration

  • 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 postponescheduled elective surgery)

  • Patient who is willing to complete a patient diary and questionnaires

Exclusion

Exclusion Criteria:

  • Patient who has a medical history including neurological disorders, infectiousdiseases, damage, surgery or medication history and that is judged to be related topremature 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 6months

  • Patient whose female partner is less interested in sexual intercourse or has a sexualdisorder

  • Patient whose female partner is pregnant

  • Patient whose female partner of childbearing age is not willing to use proper birthcontrol

  • Patient whose IIEF-EF score is 25 and less

  • Medical history of convulsive diseases, mental diseases, E.C.T (Electroconvulsiveshock Treatment), glaucoma

  • Patient who has taken concomitantly prohibited medicines before the study and who isnot willing to stop the medications for appropriate wash-out period

Study Design

Total Participants: 297
Study Start date:
November 01, 2015
Estimated Completion Date:
June 30, 2016

Study 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.

Connect with a study center

  • Inje University Ilsan Paik Hospital

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • National Health Insurance Service Ilsan Hospital

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Catholic Medical Center Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Catholic university of Korea Uijeongbu St.Mary's Hospital

    Uijeongbu-si,
    Korea, Republic of

    Site Not Available

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