Clinical Trial: Trial of PED-1 in Male Patients With Premature Ejaculation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Prema

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

Detailed Summary: 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.
Sponsor: Symyoo

Current Primary Outcome: Intravaginal ejaculation latency time (IELT)(seconds) [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Drug coitus interval time (hours) [ Time Frame: 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Symyoo

Dates:
Date Received: September 18, 2011
Date Started: September 2011
Date Completion:
Last Updated: October 1, 2012
Last Verified: October 2012