Evaluating the effect of Megestrol and metformin on endometrial hyperplasia
Design
Our sample size is 60 people, with 30 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 6.
Settings and conduct
This study, clinical trials, double-blind, placebo- control, single center are conducted in Arash women's hospital
The random allocation list for patients is solely available to the epidemiologist for 60 patients. When a doctor announces the eligibility of a patient, the methodologist will provide the doctor with the envelope. None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is the third person who is unaware of the random allocation process and type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Endometrial hyperplasia No contraindications to treatment with metformin Creatinine clearance greater than 90ml / min Hemoglobin level above 10 Normal hepatic markers Body mass index less than 25.
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. Allergy to metformin
Intervention groups
group1, beside receiving treatment of 40 mg Megestrol daily for 14 days of menstrual cycle for 3 months , will be treated with placebo (two pills) for12 weeks. Group 2, beside receiving treatment of 40 mg Megestrol daily for 14 days of menstrual cycle for 3 months , will be treated with metformin by dose of 1000 mg (twopills) for12 weeks.
Main outcome variables
Endometrium thickness and uterine bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140820018866N6
Registration date:2018-09-04, 1397/06/13
Registration timing:registered_while_recruiting
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
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
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2015-11-07, 1394/08/16
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Megestrol and metformin on endometrial hyperplasia in woman attending to Arash hospital
Public title
Evaluating the effect of Megestrol and metformin on women with endometrial hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endometrial hyperplasia
No contraindications to treatment with metformin
Creatinine clearance greater than 90ml / min
Hemoglobin level above 10
Normal hepatic markers
Body mass index less than 25.
18-72 years old
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.
Allergy to metformin
Age
From 18 years old to 72 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
En Our sample size is 60 people, with30 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 60sequences of treatments will be written accordingly, and then the cards will be placed in sealed envelopes. On each 10-digit random code packet, the order is written and the framework is written that the patient identification number is relevant and the methodologist will simply be aware of the design of the code. When a doctor announces the eligibility of a patient, the methodologist will provide the doctor with the envelope. The treatment is selected based on the type mentioned in the envelope. None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is the third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-11-04, 1394/08/13
Ethics committee reference number
IR.TUMS.REC.1394.1101
Health conditions studied
1
Description of health condition studied
Endometrial hyperplasia
ICD-10 code
N85.0
ICD-10 code description
Endometrial hyperplasia
Primary outcomes
1
Description
Improvement of endometrial hyperplasia
Timepoint
befor treatment,3 months after start treatment
Method of measurement
Review of Pathology and evaluation of uterine bleeding
2
Description
The thickness of the uterine endometrium
Timepoint
Every month for 3 times
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Comparison of BMI
Timepoint
Before and end of the study
Method of measurement
Measure weight and height
2
Description
Comparison of blood and kidney and liver indices
Timepoint
Before and end of the study
Method of measurement
Blood sampling and measuring renal and kidney function test
3
Description
Comparison of FBS
Timepoint
Before and end of the study
Method of measurement
Blood sampling
Intervention groups
1
Description
Control group, beside receiving treatment of 40 mg Megestrol daily for 14 days of menstrual cycle for 3 months , will be treated with placebo (two pills) for12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group, beside receiving treatment of 40 mg Megestrol daily for 14 days of menstrual cycle for 3 months , will be treated with metformin by dose of 1000 mg (twopills) for12 weeks.