Trial of PED-1 in Male Patients With Premature Ejaculation

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symyoo
• Treatments: Clomipramine

Criteria

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