In this double-blind, placebo-controlled, randomized clinical trial, the effects of tramadol, paroxetine and placebo in the treatment of premature ejaculation will be investigated. All of the participants would be enrolled in the study after medical and sexual examination and rejecting erectile dysfunction. Eligible patients would be divided into 3 groups, randomly. A group will be treated with tramadol 50 mg, another group will be treated with paroxetine 30 mg and third group will receive placebo. The medications will used on demand (3-4 hours before intercourse). Before beginning treatment, patients should be asked to measure their mean Intravaginal ejaculation latency time (IELT), at least the 3 last intercourses in a row by using a stopwatch. At the end of 12 weeks, the mean measured Intravaginal ejaculation latency time (IELT) by the patient in the last 3 weeks (including at least 3 intercourses) will be calculated. The PEP (Premature Ejaculation Profile) inventory will be completed separately for each patient at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008304582N2
Registration date:2014-10-04, 1393/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of Tramadol, Paroxetine and placebo in patients with life long premature ejaculation
Public title
Comparison of efficacy and safety of Tramadol, Paroxetine and placebo in treatment of life long premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least one year of their marriage is past; to be between 18-50 years of age; have the possibility of intercourse at least once a week, ability to read and write
Exclusion criteria: People who have a history of mental diseases, a physical illness such as diabetes and liver disease, alcohol or drug abuse, a history of surgery that has been effective on sexual function; history of endocrine disease, prostatitis; history of paroxetine and tramadol during the last 3 months
Age
From 18 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Gas Square, Vice-Chancellor for Research of Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2014-08-19, 1393/05/28
Ethics committee reference number
1930231601
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
Intravaginal ejaculation latency time (IELT)
Timepoint
Baseline and 3 months after treatment
Method of measurement
Ask the patient based on the PEP Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Tramadol 50 mg, 3 to 4 hours before the intervention (on demand) for 12 weeks
Category
Treatment - Drugs
2
Description
Paroxetine 20 mg, 3 to 4 hours before the intervention (on demand) for 12 weeks
Category
Treatment - Drugs
3
Description
Placebo, 3 to 4 hours before the intervention (on demand) for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Razi Hospital
Full name of responsible person
Dr. Reza Motiee
Street address
Clinic of Urology, Razi Hospital, Sardar Jangal Street
City
Rasht
2
Recruitment center
Name of recruitment center
Dr. Ali Hamidi Madani's Clinic
Full name of responsible person
Dr. Ali Hamidi Madani
Street address
Dr. Ali Hamidi Madani's Clinic, Hafez Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Centre
Full name of responsible person
Dr. Siavash Falahatkar
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre
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
Urology Research Center
Full name of responsible person
Dr. Reza Motiei
Position
Co worker/Resident
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
Email
urc1384@yahoo.com
Web page address
http://www.gums.ac.ir/urc/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Urologist / Associate Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
Email
a.hamidimadani@gmail.com
Web page address
http://www.gums.ac.ir/urc/
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Researcher of Urology Research Center/ Master
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
http://www.gums.ac.ir/urc/
Sharing plan
Deidentified Individual Participant Data Set (IPD)