Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation

This study is not yet open for participant recruitment.

Verified by Cairo University, April 2008

First Received: April 7, 2008 Last Updated: April 10, 2008 History of Changes

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

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

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

Resource links provided by NLM:

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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
cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Chair:

Hussein MH Ghanem, M D

Professor of Andrology & STDs

More Information

No publications provided

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

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Neurotransmitter Agents
Cholinergic Antagonists
Psychotropic Drugs
Cholinergic Agents
Serotonin Uptake Inhibitors
Citalopram

Serotonin
Muscarinic Antagonists
Mental Disorders
Peripheral Nervous System Agents
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Sexual Dysfunctions, Psychological
Citalopram
Sexual and Gender Disorders
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009