Premature Ejaculation Clinical Trial
Official title:
Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose,Randomized Controlled Study
NCT number | NCT00656552 |
Other study ID # | EPE100 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 0 |
First received | April 7, 2008 |
Last updated | April 10, 2008 |
Start date | May 2008 |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 59 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr el ainy school of medicine , Cairo university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in geometric mean IELT from baseline to four weeks. | 4 week | Yes | |
Secondary | changes in the intercourse satisfaction domain values of IIEF(Arabic version). Assessment of possible side effects | 4 week | Yes |
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