NCT02571101

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 297 (estimated)
• Sponsor: CTC Bio, Inc. · Industry
• Sex: Male
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	CDFR0812-15/25mg	Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
DRUG	CDFR0812-15/50mg	Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
DRUG	Condencia	Contains chlomipramine HCl 15mg.
DRUG	CDFR0812-Placebo	Placebo tablet of CDFR0812.
DRUG	Condencia-Placebo	Placebo tablet of Condencia

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-10-08
• Last updated: 2015-12-17

Locations

9 sites across 1 country: South Korea