This in study comparative therapeutic effects of two medicinal procedures setraline4 hours before coitus and each 12 hours in patients’ premature ejaculation refers to 501 hospital. Conditions, entry into the study were: mean age of 16 to 75 years with Intercourse at least once a week and premature ejaculation. Conditions, withdrawal from the study includes of erection dysfunction, urinary tract infections, neurological and systemic disorders, severe mental disorders, history of alcoholism, drug use or drug (Drug abuse) is considered. In this study, the total number of samples required prepared cards. Ejaculation latencies before treatment (mean time at least three times in the coitus) and the fourth week after treatment by the patient’s wife with accurately measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101415006N1
Registration date:2014-10-15, 1393/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Vahid Najafi
Name of organization / entity
Army College of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 2348 2026
Email address
vh.najafi@aja.aums.ac.ir
Recruitment status
Recruitment complete
Funding source
Army College of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of sertraline therapy for the treatment of patients with premature ejaculation
Public title
Comparison of two methods of treatment of sertraline in the treatment of premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male patients; having sex at least once a week; no disease in the form of inclusion.
Exclusion criteria: if the drug has side effects; lack of satisfaction to continue testing; couples apart during testing.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Army 501 Hospital
Street address
Tehran - Etemadzadeh - 501 Army Hospital
City
tehran
Postal code
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
15006
Health conditions studied
1
Description of health condition studied
Patients with premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation
Primary outcomes
1
Description
Premature Ejaculation
Timepoint
Before and after intervention
Method of measurement
Assessment of satisfaction spouses before and after intervention
Secondary outcomes
1
Description
Headache
Timepoint
During intervention
Method of measurement
Qualitatively, and through the person's statements
2
Description
Dizziness
Timepoint
During intervention
Method of measurement
Qualitatively, and through the person's statements
3
Description
Vomiting
Timepoint
During intervention
Method of measurement
Qualitatively, and through the person's statements. and after intervention
Intervention groups
1
Description
Treatment effects sertraline (20 mg) for 4 hours prior to sexual intercourse e in patients with early ejaculation
For 12 months
Category
Treatment - Drugs
2
Description
Treatment effects sertraline (20 mg) for 12 hours prior to sexual intercourse e in patients with early ejaculation
For 12 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
501 Army Hospital
Full name of responsible person
Vahid Najafi
Street address
Army 501 Hospital- Etemadzadeh -Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences Iranian Army
Full name of responsible person
Dr. Kamran Azma
Street address
Army 501 Hospital, Western Fatemi, Etemadzadeh, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Iranian Army
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
Army University of Medical Sciences
Full name of responsible person
Vahih Najafi
Position
Medical student
Other areas of specialty/work
Street address
hamedan- asadabad
City
Asadabad
Postal code
Phone
+98 81 2348 2026
Fax
Email
abozar.najafi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr. Bijan Rezakhaniha
Position
MD. Urology Specialist
Other areas of specialty/work
Street address
Army 501 Hospital- Etemadzadeh -Tehran
City
Tehran
Postal code
Phone
+98 910 800 2155
Fax
Email
reza.bijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of tabriz
Full name of responsible person
abozar Najafi
Position
Medical student
Other areas of specialty/work
Street address
hamedan- asadabad
City
Asadabad
Postal code
Phone
+98 988123482026
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)