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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

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

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:
    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.
Show detailed description  Show Detailed Description

  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




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