Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Premature Ejaculation	Drug: Escitalopram	Phase 0

ChemIDplus related topics:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Cairo University:

Primary Outcome Measures:

change in geometric mean IELT from baseline to four weeks. [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

changes in the intercourse satisfaction domain values of IIEF(Arabic version). Assessment of possible side effects [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Patient undergo a double- blind therapy of Escitalopram (10 mg) orally daily during breakfast (n=50) or placebo (n=50) for four weeks.

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Eligibility

Ages Eligible for Study:	20 Years to 59 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

One hundred married patients seek medical help for what they consider premature ejaculation with possible sexual intercourse equal or greater than 1 per week.

Exclusion Criteria:

Erectile dysfunction accounting to Arabic version of IIEF(International Index of Erectile Dysfunction)
Chronic psychiatric or physical illness.
Alcohol or substance abuse.
Use of psychotropic and antidepressant medication.
Patient with prostatitis
Organic illness causing limitation of SSRI use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656552

Contacts


Contact: Gamal S mohammed, M.B., B.Ch	20-10-184-9656	gamal77soltan@yahoo.com

Locations


Egypt
	Kasr el ainy school of medicine , Cairo university	Not yet recruiting
	cairo, Egypt
	Principal Investigator: Gamal S mohammed, M.B., B.Ch

Sponsors and Collaborators

Cairo University

Investigators


Study Chair:	Hussein MH Ghanem, M D	Professor of Andrology & STDs

More Information

Responsible Party:	Gamal Soltan ( kasr elainy school of medicine )
Study ID Numbers:	EPE100
First Received:	April 7, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00656552
Health Authority:	Egypt: Institutional Review Board

Study placed in the following topic categories:

Dexetimide

Citalopram

Serotonin

Additional relevant MeSH terms:

Parasympatholytics

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Psychotropic Drugs

Antiparkinson Agents

Cholinergic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Muscarinic Antagonists

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Cairo University
Information provided by:	Cairo University
ClinicalTrials.gov Identifier:	NCT00656552