Objectives: The objective of this study is evaluating the effect of hyperthyroidism treatment on serum prolactine level.
Design: This study is a pre-test, post-test one and the level of serum prolactine is measured in hyperthyroidism patients pre and post intervention
Setting and Conduct: Hyperthyroidism patients which were eligible to participate in the study will be treated and their serum prolactine level is measured before and after treatment.
Participants: Female hyperthyroidism patients aged 15-50 years whom do not use any pharmaceutical agent which increases prolactine level
Interventions: Administering anti-hyperthyroidism agents
Main outcomes: Serum prolactine level
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207191774N4
Registration date:2012-12-30, 1391/10/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-30, 1391/10/10
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman, Vice chancellor for Research and Technology of University of Medical Sciences, Tahmasb Abad crossroads, the begining of Jahad Boulevard, the begining of Ebn-e-Sina street, In front of Besat clinic
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the effect of hyperthyroidism treatment on serum prolactine level in female hyperthyroidism patients of pregnancy age (15-50 y)
Public title
Study of serum prolactin level in women with Hyperthyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Women with hyperthyroidism; Age between 15 to 50 years
Exclusion criteria :
use of drugs which increase prolactine level: dopamine receptor blocker including phenotiazine,chlorpromazin,perfenazine,butirofenon,haloperidole,thioxantine,metocloperamide ; dopamin synthesis inhibitor(etc. methyldopa) ;cathecolamin releasing agent: reserpin; Opiates ;H2 blockers including cimetidin,ranitidin; Imipramin,Amitriptylin; serotonin intake inhibitor:Fluoxetin; Calcium channel blockers:Verapamil; hormones: Estrogens;Antiandrogens,TRH; Others:pregnancy,lactation,liver disease,chronic kidney disease.
Age
From 15 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Vice chancellor for Research and Technology of kerman university of medical scienc
Street address
Kerman, Vice chancellor for Research and Technology of University of Medical Sciences, Tahmasb Abad crossroads, the begining of Jahad Boulevard, the begining of Ebn-e-Sina street, In front of Besat clinic
City
Kerman
Postal code
7619813159
Approval date
2012-08-23, 1391/06/02
Ethics committee reference number
91193
Health conditions studied
1
Description of health condition studied
hyperthyroidism
ICD-10 code
E05.9
ICD-10 code description
Hyperthyroidism NOS
Primary outcomes
1
Description
serum prolactine level
Timepoint
Pre-treatment; post-treatment
Method of measurement
ICMA
Secondary outcomes
empty
Intervention groups
1
Description
methimazole (20mg) is administered to the patients for 2 months.
Category
Treatment - Drugs
2
Description
in this study, primary serum level of prolactine before the initiation of metimazole administration is considered as the control value. no drug/placebo group is defined for this study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
kerman afzalipour hospital
Full name of responsible person
Dr. KHatereh Mohammadi
Street address
kerman, Imam highway, AfzaliPour Landscape, AfzaliPour Training- Health Center, Adjacent to Bahonar University
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology of kerman University of Medical Sciences, Physiology res
Full name of responsible person
Dr.Hamid Najafi pour
Street address
Kerman, Vice chancellor for Research and Technology of University of Medical Sciences, Physiology research center, Tahmasb Abad crossroads, the begining of Jahad Boulevard, the begining of Ebn-e-Sina street, In front of Besat clinic
City
Kerman
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 and Technology of kerman University of Medical Sciences, Physiology res
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 afzalipour hospital
Full name of responsible person
Dr. Mojgan Sanjari
Position
Associated professor
Other areas of specialty/work
Street address
Kerman, Imam highway, AfzaliPour Landscape, AfzaliPour Training- Health Center, Adjacent to Bahonar University