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

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTC Bio, Inc.
• Collaborator: Symyoo
• Treatments: Clomipramine; Sildenafil Citrate

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