Trial of PED-1 in Male Patients With Premature Ejaculation

A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation

The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.

Inclusion Criteria:

• Informed consent for subjects and partners
• Men 20-65 ages
• Stable monogamous relation at least for 6 mo
• Premature Ejaculation Diagnosis Tool (PEDT) more than 9
• At least 6 mo of premature ejaculation Hx
• IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period

Exclusion Criteria:

• History of medical or psychiatric illness
• Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
• Partner sexual dysfunction
• Known hypersensitivity to clomipramine and contraindications for clomipramine