Clinical Trial: Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose,Randomized Controlled Study

Brief Summary:

Escitalopram has been claimed to have the highest selectivity for the human serotonin transporter relative to the noradrenaline or dopamine transporters. This might be associated with greater clinical efficacy. Most adverse events reported by escitalopram-treated patients are mild and transient.

In this study, we compare escitalopram with placebo in the treatment of PE.

Detailed Summary:

Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized controlled Study

Introduction

From an epidemiological perspective, premature ejaculation (PE) has been reported as the most common male sexual dysfunction with overall prevalence rates estimated at around 30% .(Laumann et al., 1999).

PE is defined by the Diagnostic and Statistical Manual of Mental Disorders(revision IV) (DSM-IV-TR) as 'the persistent or recurrent ejaculation with minimal stimulation before, on, or shortly after penetration and before the person wishes it'. (American Psychiatric Association, 1994).

ISSM Definition of Premature Ejaculation is a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy (www.issm.info).

Premature ejaculation has been associated with erosion in sexual self-confidence and low sexual satisfaction in men and their female partners.( Byers & Grenier ; 2003).

Behavioral therapy and psychological counseling are the historically initial approaches in the treatment of PE.However There is no evidence that non-drug therapy is able to guarantee long-term cure or improvement of PE. (Rosen, 2004).

These techniques require active involvement of the patients and their partners and the benefits are generally short-lived, and patient
Sponsor: Cairo University

Current Primary Outcome: change in geometric mean IELT from baseline to four weeks. [ Time Frame: 4 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: changes in the intercourse satisfaction domain values of IIEF(Arabic version). Assessment of possible side effects [ Time Frame: 4 week ]

Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: April 7, 2008
Date Started: May 2008
Date Completion:
Last Updated: April 10, 2008
Last Verified: April 2008