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Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Cairo University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT00656552
First received: April 7, 2008
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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:
    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

  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

No publications provided

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

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 21, 2013