Comparative effectiveness of letrozole and methformin on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia utreus cancer in alzahra hospital.
The main objective of this study is The effect of letrozole and methformin on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia utreus cancer. This study will be conducted on 90 women with abnormal uterine bleeding were referred to the Alzahra hospital. They are done for endometrial biopsy and pathology reports, endometrial hyperplasia or endometrial cancer or abnormal proliferative glands have been reported. If they are allergic to letrozole, metformin and severe liver disease, uncontrolled hypertension, thromboembolism will be excluded. Patients are divided into three groups according to the type of event. All patients concurrently administered drug letrozole (made in Iran, Iran Hormone) 2.5 mg BID and 500 mg BID metformin for three months. After 3 months to be taken again from the people endometrial biopsy specimens were reviewed by 2 pathologists. Results of before and after treatment will be compared by a Gynecologic Oncology and Pathology results can be considered as the primary outcome to compare the response to treatment in patients with pathological criteria. If the diagnosis of endometrial cancer, endometrial biopsies at the time just to prepare the patient for surgery, both drugs given at least two weeks then, before the intervention compared with biopsy confirmed after hysterectomy. This is a not blinded study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412085563N6
Registration date:2015-01-03, 1393/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2014-12-14, 1393/09/23
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness of letrozole and methformin on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia utreus cancer in alzahra hospital.
Public title
The effect of letrozole and methformin on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia utreus cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with abnormal uterine bleeding and havingdisordered proliferative or hyperplastic endometrium and uterine cancer;Consent to participate
Exclusion criteria:People who are allergic to metformin and letrozole, severe impairment of hepatic function; Uncontrolled high blood pressure; Thromboembolism
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Vice chancellor for Research,Tabriz University Of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
9347
Health conditions studied
1
Description of health condition studied
Patients with abnormal bleeding and endometrial proliferative and Hayprplastyk with irregular glands
ICD-10 code
N85.0
ICD-10 code description
Endometrial glandular hyperplasia
Primary outcomes
1
Description
Histologic types of endometrial
Timepoint
Three months after the first dose
Method of measurement
Microscopic examination
Secondary outcomes
empty
Intervention groups
1
Description
In the third group with cervical cancer:Drug letrozole (made in Iran, Iran Hormone) 2.5 mg BID and 500 mg BID Metformin is prescribed for three months.
Category
Treatment - Drugs
2
Description
Group II endometrial proliferative effect:Drug letrozole (made in Iran, Iran Hormone) 2.5 mg BID and 500 mg BID Metformin is prescribed for three months.
Category
Treatment - Drugs
3
Description
The first group with abnormal uterine bleeding: Drug letrozole (made in Iran, Iran Hormone) 2.5 mg BID and 500 mg BID Metformin is prescribed for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
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,Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com; lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com; lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com; lahroudin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)