Clinical Trial: Phase 2 Trial of PED-1 and PED-2 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 Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With <
Brief 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 Summary: 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.
Sponsor: Symyoo
Current Primary Outcome: Fold cahnges of Intraviginal ejaculation latency time (IELT) [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Drug coitus interval time [ Time Frame: 4 week ]
Original Secondary Outcome: Same as current
Information By: Symyoo
Dates:
Date Received: September 14, 2010
Date Started: September 2010
Date Completion:
Last Updated: October 1, 2012
Last Verified: October 2012