The aim of this study is the evaluation of clomiphene efficacy in patients with idiopathic premature ejaculation(IPE).in this study we intered 126 IPE patients with age ranges 24 – 57 years old and they randomized to two groups( study and control) by computer generated random numbers then,the study and control groups double blindy received daily 50mg clomiphene oraly, and placebo respectively for 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501071981N6
Registration date:2015-02-09, 1393/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-09, 1393/11/20
Registrant information
Name
Ali Asghar Ketabchi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 4348
Email address
a_ketabchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-02-21, 1390/12/02
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of clomiphene in the Treatment of idiopathic premature Ejaculation: A double-blind placebo controlled study
Public title
Evaluation of clomiphene effect in the Treatment of idiopathic premature Ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Inclusion : male ;married; idiopathic premature ejaculation
exclusion criteria : single ; Known cause premature ejaculations
Age
From 24 years old to 57 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
physiology research center,University of Kerman Medical Sciences
Street address
University of Kerman Medical Sciences
City
Kerman
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
K/93/529
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
duration of ejaculation
Timepoint
after 3 months intervention
Method of measurement
with cronometer from erection to ejaculation by patients wife
Secondary outcomes
1
Description
sexuality indices
Timepoint
before and after 3 months intervention
Method of measurement
by questinaires
Intervention groups
1
Description
In intervention group oraly 50 mg clomiphene daily for 3 months
Category
Treatment - Drugs
2
Description
in control group oraly placebo ,daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Department ,Bahonar Hospital
Full name of responsible person
Dr.Ali Asghar Ketabchi
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physiology Research Center , Kerman University of Medical Sciences
Full name of responsible person
Dr. Hamid Najafi
Street address
Research Building, Somaie Square
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physiology Research Center , Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr.Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department , Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
dr.ketabchi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department ,Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
dr.ketabchi@gmai.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department,Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
dr.ketabchi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)