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Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656552
Recruitment Status : Unknown
Verified April 2008 by Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2008
Last Update Posted : April 11, 2008
Information provided by:
Cairo University

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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: Escitalopram Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose,Randomized Controlled Study
Study Start Date : May 2008
Estimated Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656552

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Contact: Gamal S mohammed, M.B., B.Ch 20-10-184-9656

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Kasr el ainy school of medicine , Cairo university
Cairo, Egypt
Principal Investigator: Gamal S mohammed, M.B., B.Ch         
Sponsors and Collaborators
Cairo University
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Study Chair: Hussein MH Ghanem, M D Professor of Andrology & STDs
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Responsible Party: kasr elainy school of medicine, Gamal Soltan Identifier: NCT00656552    
Other Study ID Numbers: EPE100
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs