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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symyoo
• Treatments: Clomipramine

Criteria

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