NCT01439984

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (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 is more effective than Placebo in the treatment of premature ejaculation.

Detailed description

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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	Clomipramine	Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-09-23
• Last updated: 2012-10-03

Locations

5 sites across 1 country: South Korea