Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation

The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.

Inclusion Criteria:

• Informed consent for subjects and partdners
• Men 20-65
• stable monogamous relation at least for 6 mn
• PEDT more than 9
• at least 6 Mn of premature ejaculation Hx
• IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period

Exclusion Criteria:

• Hx of medical or psychiartric illness
• erectile dysfunction (<21 IIEF EF domain score) or other forms of sexual dysfunction
• Partner sexual dysfunction
• known hypersensitivity to clomipramine and contraindications for clomipramine