NCT00656552

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

April 7, 2008

Last Update Submit

April 10, 2008

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

  • change in geometric mean IELT from baseline to four weeks.

    4 week

Secondary Outcomes (1)

  • changes in the intercourse satisfaction domain values of IIEF(Arabic version). Assessment of possible side effects

    4 week

Interventions

EscitalopramDRUG

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

Eligibility Criteria

Age20 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el ainy school of medicine , Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hussein MH Ghanem, M D

    Professor of Andrology & STDs

    STUDY CHAIR

Central Study Contacts

Gamal S mohammed, M.B., B.Ch

CONTACT

20-10-184-9656gamal77soltan@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

EG(1)