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Effects of metformin in the treatment of endometrial hyperplasia

Phase 2
Conditions
endometrial hyperplasia.
Hyperplasia of endometrium: NOS cystic glandular-cystic polypoid
Registration Number
IRCT2014082018866N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
64
Inclusion 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. 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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement of endometrial hyperplasia. Timepoint: befor treatment,3 months after start treatment. Method of measurement: Review of Pathology.
Secondary Outcome Measures
NameTimeMethod
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.;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.;Effect of metformin in reduce blood glocose. Timepoint: start treatment and 3 months after that. Method of measurement: blood sampling and Blood glucose measurement.;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.
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