Assessment of the effect of hypothyroidism treatment with levothyroxine on the improvement of benign breast disorders in women attending the breast clinic of Arash Womens Hospital.
The aim of this study is to determine the effect of hypothyroidism treatment with levothyroxine on benign breast disorders in women attending the breast clinic of Arash Women's Hospital .This double blind ,non randomized study to be conducted with control group in one center .Inclusion criteria include Women with fibrocystic disease , mild and moderate mastalgia , nipple discharge
Exclusion criteria include :The patient considered for surgical intervention; pregnant women , women taking oral contraception pill , history of breast cancer ;high levels of prolactin , history of hyperthyroidism or hypothyroidism. Among women with benign breast disorder attending the breast clinic of Arash Women's Hospital, 31 women with hypothyroidism (case group)and 31euthyroidism women (control group)will enrolled in this study.Case group are treated with levothyroxine for three months.Before and after intervention, breast pain intensity, intensity of fibrocystic disorders and nipple discharge are evaluated by ultrasound and clinical examination of breast and visual analog scale.Then we will evaluate and compare this finding in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206264329N3
Registration date:2012-08-30, 1391/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-30, 1391/06/09
Registrant information
Name
Sadaf Alipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982177888751 - 00982177883195
Email address
salipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of hypothyroidism treatment with levothyroxine on the improvement of benign breast disorders in women attending the breast clinic of Arash Womens Hospital.
Public title
The effect of hypothyroidism treatment with levothyroxine on improvement of benign breast disorders
Purpose
Screening
Inclusion/Exclusion criteria
Women with fibrocystic disease;Mild and moderate mastalgia ; nipple discharge : Inclusion criteria.
The patient considered for surgical intervention; Pregnant women ; Women taking oral contraception pill ;history of breast cancer ;High levels of Prolactin ;History of hyperthyroidism or hypothyroidism: Exclusion criteria
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research ،Tehran University of Medical Science,
Street address
Qods St, Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2012-08-01, 1391/05/11
Ethics committee reference number
60338
Health conditions studied
1
Description of health condition studied
Fibrocystic mastopathy
ICD-10 code
N60/1
ICD-10 code description
Diffuse cystic mastopathy
2
Description of health condition studied
Mastodynia
ICD-10 code
N64/4
ICD-10 code description
Mastodynia
3
Description of health condition studied
Nipple discharge
ICD-10 code
N64/5
ICD-10 code description
Other signs and symptoms in breast/nipple discharge
Primary outcomes
1
Description
intensity of benign breast disorders
Timepoint
Befor and 3 months after intervention
Method of measurement
Clinical exam.Ultrasound .Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
there is no intervention in the control group.
Category
N/A
2
Description
intervention in the case group is administration of tablet levothyroxine with 50 Micrograms initial dose , for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women 's Hospital
Full name of responsible person
Sadaf Alipour.Assistant of professor of surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences,Deputy of Research
Full name of responsible person
Akbar Fotohi
Street address
Qods St,Keshavarse Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences,Deputy of Research
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
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Assistant of professor of Surgery
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ladan Hosseini
Position
MS/Employee of Research Deveploment Center
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
hosseiniladan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ladan Hosseini
Position
MS/Employee of Research Development Center
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
hosseiniladan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)