A Prospective, Randomized, Double-blinded, Active-control, 3-Treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of On-demand Therapy with CDFR0812-15/50mg Compared to On-demand Therapy with Single-drug Administration of Clomipramine HCl 15mg or Sildenafil citrate 50mg in Male Patients Diagnosed with Premature Ejaculation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004362

Enrollment

792

Registered

2019-10-22

Start date

2019-10-28

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : CDFR0812-15/50mg 1 tablet or Condencia tab 15mg 1 tablet or Viagra tab 50mg 1 tablet on demand for 12 weeks

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Subjects who voluntarily consented, after listing enough explanation for this study and investigational product. 2) Informed consent for partner 3) Men, over 19 years and under 65 years 4) Diagnostic and Statistical Manual of Mental Disorders (DSM)-V defined Premature Ejaculation Medical History 5) More than 11 points in the Korean version of the Premature Ejaculation Diagnostic Table (PEDT) 6) 'Personal despondency' or 'Relative impediment' of PEP Questionnaire items is more than moderate 7) Subjects who are communicative 8) Subjects who is willing to complete the study diary card

Exclusion criteria

Exclusion criteria: 1) IIEF-EF domain score 180mmHg or Stabilizer EBP > 110 mmHg measured during a screening visit) 7) Subjects who has digestive system with expected to have drug absorption disorder 8) Chronic liver disease or liver failure of severe disease (AST or ALT >3 x ULN) 9) Subjects with hepatitis B and hepatitis C or HIV positive 10) Known hypersensitivity to clomipramine, Sildenafil and contraindications for clomipramine, sildenafil

Design outcomes

Secondary

Measure	Time frame
The average absolute value change of IELT as measured in Per Visit relative to the baseline;The average fold change of IELT as measured in Per Visit relative to the baseline	—

Primary

Measure	Time frame
The average absolute value change of IELT as measured in Visit 5 relative to the baseline	—

Countries

Korea, Republic of

Contacts

Public ContactDu-Geon Moon

Koera University Guro Hospital

uromoon@gmail.com+82-2-2626-3201

Outcome results