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Compare the effect of the drug Letrozole and Megestrolto treat abnormal uterine bleeding

Phase 2
Conditions
simple hyperplasia.
No inflammatory disorders of female genital trac
N80-N98
Registration Number
IRCT2015031011504N5
Lead Sponsor
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
50
Inclusion Criteria

Age 44 to 50 years, Having abnormal uterine Hemorrhage, simple hyperplasia without Atypia present in the endometrial biopsy, agreement to take part in the study, abnormal thickening of the endometrium (more than 12millimeterin reproductive age sand the pre- menopausal or the presence of endometrium 5 to 12millimeters in reproductive ages and pre- menopausal along with abnormal bleeding continuation despite medical treatment) intrans vaginal ultrasound(first evaluation via basic trans-vaginal ultrasound will be done for all research units by the sonography and in case of abnormal endometrium thickness (more than12millimeters), these people will inter the study; Exclusion criteria: Performing hormone therapy during the last 6 months, wanting to get pregnantfor at least 3 months from now, focal endometrial lesions such as Leiomyoma, having Atypi color complexly perplasia, flushing symptoms, Sleep Disorders, mood changes during the last 3 months, Breast-feeding, Having congenital uterine disorders, Hypothyroidism, Hypertension, history of vascular disease or clotting disorders, sensitivity to Progestin’s.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Endometrial hyperplasia without Atypia simple cytologic. Timepoint: Before and after the intervening. Method of measurement: Trans-vaginal ultra sound and endometrial biopsy basis.;Abnormal uterine bleeding. Timepoint: Before and after the interference(the twentieth to twenty fourth day of menstrual cycle). Method of measurement: Trans-vaginal ultra sound and endometrial biopsy basis.;Premenopausal. Timepoint: Before and after the interference(20 to 24menstrual cycles). Method of measurement: Measuring the serum level of follicle-stimulating hormone.
Secondary Outcome Measures
NameTimeMethod
Estradiol. Timepoint: Before and after the intervention. Method of measurement: Serum levels of Estradiol.;Endometrial thickness. Timepoint: Before and after the intervening. Method of measurement: The wall thickness of the Endometrial based on ultrasound.;Side effects of taking Letrozole and Megestrol acetate. Timepoint: Once per month. Method of measurement: Genera sensitivity, itching, hives and monthly sonography.;Triglyceride. Timepoint: Before and after the intervention. Method of measurement: Blood levels of triglycerides.;Cholesterol. Timepoint: Before and after the intervention. Method of measurement: Blood levels of cholesterol.;Menstrual status. Timepoint: Before and after the intervention. Method of measurement: Oligomenorrhea, Polymenorrhea ,normal.
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