The purpose of this study is to evaluate the effects of sertraline on semen parameters in men with premature ejaculation in Akhavan hospital clinic. In this double blind clinical trial 60 men with premature ejaculation (latency time less than 2min) who meet the inclusion criteria, will be randomly divided into 2 groups (case: 30 patients/sertraline 25mg/day, increasing dose to 50mg/day in first week, 3 months) and control group (30 patients/squeeze, start-stop technics/0, 4th, 8th weeks of study). Semen samples will be tested in 0, 3th week after clinic admission, 3 months after treatment and 3 weeks after completion of treatment. CASD and SCD technics will be used in semen evaluation and premature ejaculation will be evaluated in first visit and 4th, 8th and 12th week after treatment by self-reporting PE questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111178121N1
Registration date:2011-12-11, 1390/09/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-12-11, 1390/09/20
Registrant information
Name
Leila Sirati
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1224 8960
Email address
sirati_l@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sertraline on semen parameters in men with premature ejaculation
Public title
Effect of sertraline on semen parameters in men with premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age18-40; married men without any history of known sexual disorders; no cigarettes smoking or any drug abuse or alcohol consumption; BMI: 20-28. Exclusion criteria: drug holding because of severe adverse effects of sertraline or no suitable effects ( by patient ); loss of patients; patient with current or past history of psychological disorders like depression or chemotherapy or radiotherapy; patient with current or past history of seizure or clinical varichocele ; patient with current or past history of chronic disease like diabetes, cirrhosis, uremia,..; desire to have a child in time of study.
Age
From 18 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Kashan University of medical sciences
Street address
Kashan university of medical sciences.
City
Kashan
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
9037
Health conditions studied
1
Description of health condition studied
premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation
Primary outcomes
1
Description
premature ejaculation
Timepoint
0, 2nd week and 1st, 2nd, 3rd month after treatment
Method of measurement
self reporting questionnaire
2
Description
sperm count
Timepoint
first visit and 3 weeks after that/3 months after treatment and 3 weeks after Completion of treatment
Method of measurement
spermogram
Secondary outcomes
1
Description
drug advers effects
Timepoint
4th, 8th, 12th week
Method of measurement
self reporting
Intervention groups
1
Description
Control group: teaching squeeze, start-stop techniques in 0, 4th, 8th, 12th week after treatment.
Category
Treatment - Drugs
2
Description
Intervention group: tab sertraline 25mg/day, increasing dose to 50 mg/day in first week for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan hospital
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Golam Ali Hamidi (PhD)
Street address
Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Leila Sirati
Position
resident of psychology
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
kashan
Postal code
Phone
0O983614443023
Fax
Email
sirati_L@kaums.ac.ir , daesmaili@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gudarz Akkashe
Position
psychologist
Other areas of specialty/work
Street address
Akhavan hospital
City
Kashan
Postal code
Phone
+98 36 1444 3023
Fax
Email
sirati_L@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)