Comprative study of therapeutic effect and Complication of Drugs of Sertraline, Flouxetine and Paroxetine each 12 hours Daily in Premature Ejaculation Patients
Design
This study is a non-randomized, non-placebo-controlled clinical trial and a comparative study on the therapeutic effect of sertraline, Flouxetine and Paroxetine every 12 hours daily in the treatment of premature ejaculation patients. Three hundred sixty patients (each group of one hundred twenty) will be surveyed from July 2018 to July 2020.
Settings and conduct
The location of the study is in the Imam Reza hospital of Tehran affiliated to the Army University of Medical Science. Patients are evaluated by an urologist and, if approved, have an early ejaculation according to the definition of DMS-4 enrollred In this study,after obtaining consent Written.
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Male with Premature Ejaculation؛ Possible at least Once Coitus on Week and Age between 20 to 75 years
Exclusion Criteria : Norologic Disorder؛ Psycologic Disorder؛ Age Less than 20 and Over 75 Years؛ Urinary and Genital Infection and History of Pelvic Surgery
Intervention groups
In the first group, it is prescribed 50 mg of sertraline, in the secound group 20 mg flouxetine and in third groug 20 mg paroxetine each 12 hours daily . Finally, the time the ejaculation before treatment (mean time in at least three coitus) and at the end of the fourth and eighth weeks after treatment are accurately measured and recorded by the patient's wife with a stopwatch . Patients are advised to record time from vaginal entrance to ejaculation
Main outcome variables
Time of Ejaculation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180401039167N2
Registration date:2018-06-25, 1397/04/04
Registration timing:prospective
Last update:2018-06-25, 1397/04/04
Update count:1
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Bijan Rezakhaniha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 6431
Email address
reza.bijan1345@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprative Study of Therapeutic Effects of Sertraline, Flouxetine and Paroxetine in Premature Ejaculation
Public title
Study of Therapeutic Effects of Sertraline, Flouxetine and Paroxetine in Premature Ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male with Premature Ejaculation
Possible at least Once Coitus a Week
Age between 20 to 75 years
Exclusion criteria:
Norologic Disorder
Age Less than 20 and Over 75 Years
Psycologic Disorder
History of Pelvic Surgery
Urinary and Genital Infection
Age
From 20 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
360
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences