Clinical Trial Details

NCT ID: NCT02571101
Date Last Changed: December 16, 2015

Overview

Research Study Summary

A clinical trial to evaluate treatments for patients with Premature Ejaculation

Research Study 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

Purpose

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

To Learn more

Recruitment Details

Phase
2
Gender
Male
Age
19 to 65 Years
Overall Status
Recruiting
Lead Sponsor
CTC Bio, Inc.
Duration
6 Months
Facility Type
N/A
Compensation

Eligibility

Male ages 19 Years to 65 Years

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

Site Locations (8)

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

Contact

Youngrang Lee
82-(0)70-4335-4759
E-mail:

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