A common treatment for endometrial hyperplasia is Hystrectomy or progesterone. On the other hand, hyper insulinemia can have a direct mytotic effect on the endometrium that inhibit progesterone therapiotic effect the on the endometrium. Metformin and insulin secretion in addition to being able to limit its increase, the ability to reduce the rate of ovarian and adrenal androgen secretion that is secreted.The study of clinical trials between Endometrial hyperplasia patients referred to the hospital a in between 1394-1393 that were detected under sampling to 32 person of any group studied for patients to be fitted into two groups divided. A group treated with progesterone therapy protocol 20-80 mg daily based on the type of hyperplasia in 14 days from the day of the menstrual cycle, 14 for three periods and other groups in addition to the first group receiving treatment progestron treated with metformin for the first 12 weeks of daily 4 weeks in the two numbers (1000 mg) and in the remaining eight weeks of daily (2000 mg) will get. At the end of the course of treatment done another sampling to treatment evaluation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082018866N1
Registration date:2014-12-29, 1393/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-29, 1393/10/08
Registrant information
Name
Afsaneh Tehranian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
afsanehtehranian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding metformin to progesterone in patients with endometrial hyperplasia admitted to Arash hospital, Tehran, Iran
Public title
Effects of metformin in the treatment of endometrial hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
In this randomized clinical trial of patients with endometrial hyperplasia admitted to Arash hospital, Tehran, Iran in 2014 were diagnosed by biopsy sample were recruited. Inclusion criteria: women aged 18 to 75 years old with endometrial biopsy confirmed by endometrial hyperplasia; no contraindications to treatment with metformin; creatinine clearance greater than 90ml / min; using the formula of Cockroft-Gault; normal hepatic markers hemoglobin level above 10; satisfactory condition; physically fit to participate in the study. Exclusion criteria: taking metformin within the past 6 months; impaired hepatic function tests, blood sugar is less than 65 and no more than 200; history of alcohol use disorder; history of vitamin B12; pregnancy; history of insulin therapy; body mass index less than 25.
Age
From 18 years old to 75 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st.
City
Tehran
Postal code
Approval date
2014-11-24, 1393/09/03
Ethics committee reference number
9111290046
Health conditions studied
1
Description of health condition studied
endometrial hyperplasia
ICD-10 code
N85.0
ICD-10 code description
Hyperplasia of endometrium: NOS cystic glandular-cystic polypoid
Primary outcomes
1
Description
Improvement of endometrial hyperplasia
Timepoint
befor treatment,3 months after start treatment
Method of measurement
Review of Pathology
Secondary outcomes
1
Description
Evaluation of the hepatic effects of metformin in the treatment of patients with Endometrial hyperplasia
Timepoint
start of treatment and 3 months after that
Method of measurement
blood sampling and liver tests measurements
2
Description
Reviews of metformin renal complications in the treatment of patients with Endometrial hyperplasia
Timepoint
start teatment and 3 months after that
Method of measurement
blood sampling and measuring hepatic function test
3
Description
effect of metformin in reduce blood glocose
Timepoint
start treatment and 3 months after that
Method of measurement
blood sampling and Blood glucose measurement
4
Description
Effect of metformin on body mass index
Timepoint
start treatment and 3 months after that
Method of measurement
Measurement of height and weight and body mass index calculator
Intervention groups
1
Description
Control group will be teated with progesterone therapy protocol of 20-80 mg daily based on the type of hyperplasia, 14 days from the day of 14th of the menstrual cycle for three periods.
Category
Treatment - Drugs
2
Description
Intervention group, beside receiving treatment of progestrone in control group , will be treated with metformin by dose of 1000 mg for the first 4 weeks,then follow by 2000 mg metformin in remaining eight weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Dr. Nasim Zarifi
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoudi Yonesian
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st.
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
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
Nasim Zarifi
Position
MD
Other areas of specialty/work
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
nasimzarifi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Afsaneh Tehranian
Position
Specialist of Obstetrics and gynaecology
Other areas of specialty/work
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
afsanehtehranian@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
Nasim Zarifi
Position
MD
Other areas of specialty/work
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3284
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)