NCT01203202

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Symyoo · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	Clomipramine	15mg and 30mg on demand

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-09-16
• Last updated: 2012-10-03

Locations

2 sites across 1 country: South Korea