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IRCT2015031011504N5 IRCT 2015-12-12 Vice Chancellor for Research and Technology, Semnan University of Medical Sciences Compare the effect of the drug Letrozole and Megestrolto treat abnormal uterine bleeding Letrozole versus Megestrol acetate for treatment of simple endometrial hyperplasia without Atypia 2015-06-15 anticipated 50 Complete https://irct.ir/trial/11741 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 simple hyperplasia. Intervention 1: He first group will be prescribed 40 milligram of Megestrol acetate (40 milligram BRENDOCARE tablet, made by Aburaihan pharmaceutical co. Iran) for two weeks in each month (A 40 milligram tablet per day). After the end of treatment, all the research units will investigate (interview and trans-vaginal Sonography) the serum Estradiol levels after the interference. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results before and after that will be compared. The results will be investigated by international standards. Intervention 2: The second group will be prescribed 2.5 milligram of Letrozole (2.5 milligram Letrax tablet, made by Aburaihan pharmaceutical co. Iran), for two months, A tablet per day. After the end of treatment, all the research units will investigate (interview and trans-vaginal Sonography) the serum Estradiol levels after the interference. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results before and after that will be compared. The results will be investigated by international standards.
public Dr Niaz Nik Khah
Amiralmomenin Hospital, Imam Hossein Square, Semnan
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3346 1433 niaz_nik@yahoo.com Semnan University of Medical Sciences scientific Dr Sanam Moradan
Amiralmomenin Hospital, Imam Hossein Square, Semnan
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3346 1433 sm42595@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) 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. 44 years 50 years Female N80-N98 No inflammatory disorders of female genital trac Treatment - Drugs Treatment - Drugs He first group will be prescribed 40 milligram of Megestrol acetate (40 milligram BRENDOCARE tablet, made by Aburaihan pharmaceutical co. Iran) for two weeks in each month (A 40 milligram tablet per day). After the end of treatment, all the research units will investigate (interview and trans-vaginal Sonography) the serum Estradiol levels after the interference. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results before and after that will be compared. The results will be investigated by international standards. The second group will be prescribed 2.5 milligram of Letrozole (2.5 milligram Letrax tablet, made by Aburaihan pharmaceutical co. Iran), for two months, A tablet per day. After the end of treatment, all the research units will investigate (interview and trans-vaginal Sonography) the serum Estradiol levels after the interference. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results before and after that will be compared. The results will be investigated by international standards. 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. 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. Vice Chancellor for Research and Technology, Semnan University of Medical Sciences Approved 2015-06-15 Ethical Committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Boulevard,Semnan Semnan Iran (Islamic Republic of)