Evaluating the effect of Megestrol and metformin on women with endometrial hyperplasia
Phase 3
- Conditions
- Endometrial hyperplasia.Endometrial hyperplasia
- Registration Number
- IRCT20140820018866N6
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.