NCT01024491

Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

A Parallel Randomized Double Blind Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: MorePharma Corporation · Industry
• Sex: Male
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation

Detailed description

Randomized, double blind, placebo controlled, prospective and parallel trial. Men with premature ejaculation using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory latency time (IELT) ≤ 3 minutes. Three treatments are to be compared: placebo, 15 mg or 20 mg paroxetine for 12 weeks.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	paroxetine	daily dose of paroxetine 15mg for 12 weeks
DRUG	paroxetine	active daily treatment with paroxetine 20 mg
DRUG	placebo	active daily treatment with placebo

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-12-02
• Last updated: 2009-12-02

Locations

2 sites across 1 country: Mexico