Last updated on December 2015

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


Brief description of study

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 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.

Clinical Study Identifier: NCT02571101

Contact Investigators or Research Sites near you

Start Over

Youngrang Lee

Inje University Ilsan Paik Hospital
Goyang-si, Korea, Republic of
  Connect »

Youngrang Lee

National Health Insurance Service Ilsan Hospital
Goyang-si, Korea, Republic of
  Connect »

Youngrang Lee

Pusan National University Hospital
Pusan, Korea, Republic of
  Connect »

Youngrang Lee

Catholic Medical Center Seoul St. Mary's Hospital
Seoul, Korea, Republic of
  Connect »

Youngrang Lee

Ewha Womans University Medical Center
Seoul, Korea, Republic of
  Connect »

Youngrang Lee

Korea University Guro Hospital
Seoul, Korea, Republic of
  Connect »

Youngrang Lee

Samsung Medical Center
Seoul, Korea, Republic of
  Connect »

Youngrang Lee

Seoul National University Hospital
Seoul, Korea, Republic of
  Connect »

Youngrang Lee

Catholic university of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si, Korea, Republic of
  Connect »