comparison of the efficacy and safety of Diphereline 3.75 mg manufactured by IPSEN (France) and Variopeptyl 3.75 mg manufactured by Varian pharmed Co (Iran) in treatment of girls with Central Precocious Puberty (CPP)
Design
In this research, 36 eligible girls with Central Precocious Puberty referring to endocrinology clinic of Shahid Sadughi medical science university of Yazd were chosen purposefully and divided into two control and intervention groups.
Settings and conduct
patients after clinical and laboratory examination and confirmation of CPP in endocrinology clinic of Shahid Sadughi medical science university of Yazd divided and treated into two control and intervention groups, this study is not blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: girls under 8 years, with confirmed central precocious puberty (CPP) after the clinical & laboratory (FSH, LH, Estradiol ) & Uterus and ovaries sonography examinations also Previously, they have not been treated for CPP and signed Informed Consent Form. Exclusion criteria: If the patient's have any ADR to the drug or the patient's dissatisfaction with the continuation of the study.
Intervention groups
Diphereline 3.75 mg manufactured by IPSEN (France) and Variopeptyl 3.75 mg manufactured by Varian pharmed Co (Iran)
Main outcome variables
Decrease levels of FSH, LH, and Estradiol hormones
General information
Reason for update
Acronym
Central Precocious Puberty (CPP)
IRCT registration information
IRCT registration number:IRCT20170225032759N1
Registration date:2017-12-03, 1396/09/12
Registration timing:retrospective
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Amir Mansour Jalali Nadooshan
Name of organization / entity
Varian Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 2485 2480
Email address
a.jalali@varianpharmed.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2016-06-09, 1395/03/20
Trial completion date
empty
Scientific title
Comparison of efficacy of Diphereline and Variopeptyl in treatment of girls with idiopathic central precocious puberty
Public title
Comparison of efficacy of Diphereline ( IPSEN, France) and Variopeptyl (Varian pharmed, IRAN) in treatment of girls with idiopathic central precocious puberty (CPP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
girls under 8 years, with confirmed central precocious puberty (CPP)
signed Informed Consent Form
Exclusion criteria:
girls older 8 years
Age
From 2 years old to 8 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Actual sample size reached:
35
Randomization (investigator's opinion)
N/A
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
Shahid Sadoughi Yazd University of Medical Science
Street address
Shahid Sadoughi University of Medical Science, Allam Sq, Safaeiyeh St,
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.386
Health conditions studied
1
Description of health condition studied
central precocious puberty
ICD-10 code
E22.8
ICD-10 code description
E22.8
Primary outcomes
1
Description
LH
Timepoint
befor intervention then 28 days after injections (days 0-28-56-84)
Method of measurement
Cm
2
Description
FSH
Timepoint
befor intervention then 28 days after injections (days 0-28-56-84)
Method of measurement
Iu/L
3
Description
Estradiol
Timepoint
befor intervention then 28 days after injections (days 0-28-56-84)
Method of measurement
Iu/L
Secondary outcomes
1
Description
Hight
Timepoint
befor intervention then 28 days after injections (days 0-28-56-84)
Method of measurement
cm
2
Description
wieght
Timepoint
befor intervention then 28 days after injections (days 0-28-56-84)
Method of measurement
Kg
Intervention groups
1
Description
Treatment with use of Diphereline 3.75 mg (triptorelin) manufactured by IPSEN (France) every 28 days for 3 months
Category
Treatment - Drugs
2
Description
Treatment with use of Variopeptyl 3.75 mg (triptorelin) manufactured by IPSEN (IRAN) every 28 days for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Mahtab ordooei
Street address
Safaeiyeh, Allam Sq
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9138
Email
dr.ordooei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Mahtab Ordooei
Street address
Sadoughi University of Medical Science
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9138
Email
dr.mansourjalali@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mahtab ordooei
Position
Pediatric endocrinology/Phd
Latest degree
Ph.D.
Other areas of specialty/work
Pediatric endocrinology
Street address
Safaeiyeh, Allam Sq
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353183737
Fax
Email
dr.ordooei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mahtab ordooei
Position
Pediatric endocrinology/Phd
Latest degree
Ph.D.
Other areas of specialty/work
Pediatric endocrinology
Street address
Safaeiyeh, Allam Sq
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353183737
Fax
Email
dr.ordooei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Varian Pharmed
Full name of responsible person
Dr. Amir mansour jalali nadooshan
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
#19, Parvin St, Vali e Asr St.
City
Tehran
Province
Tehran
Postal code
1966834944
Phone
+98 21 2485 2480
Fax
+98 21 2485 2480
Email
dr.mansourjalali@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available