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IRCT20140820018866N6 IRCT 2018-09-04 Tehran University of Medical Sciences Evaluating the effect of Megestrol and metformin on women with endometrial hyperplasia Evaluating the effect of Megestrol and metformin on endometrial hyperplasia in woman attending to Arash hospital 2015-11-07 anticipated 60 Complete https://irct.ir/trial/17000 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Endometrial hyperplasia. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Afsaneh Tehranian
Arash women hospital, Rashid street, Resalat highway,Tehranpars
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 afsanehtehranian@yahoo.com Tehran University of Medical Sciences scientific Dr. Afsaneh Tehranian
Arash Womens Hospital, Rashid Avenue, Resalat Highway, Tehranparse
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 afsanehtehranian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 72 years Female 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 N85.0 Endometrial hyperplasia Treatment - Drugs Treatment - Drugs 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. 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. Improvement of endometrial hyperplasia. Timepoint: befor treatment,3 months after start treatment. Method of measurement: Review of Pathology and evaluation of uterine bleeding. The thickness of the uterine endometrium. Timepoint: Every month for 3 times. Method of measurement: Ultrasonography. Comparison of BMI. Timepoint: Before and end of the study. Method of measurement: Measure weight and height. 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. Comparison of FBS. Timepoint: Before and end of the study. Method of measurement: Blood sampling. Tehran University of Medical Sciences Approved 2015-11-04 Ethics committee of Tehran University of Medical Science Tehran University of Medical Science, Qods Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)