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IRCT20200531047614N3 IRCT 2021-01-20 Kashan University of Medical Sciences The effects of isoflavone supplementation in the treatment of non atypical endometrial hyperplasia The effects of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with non atypical endometrial hyperplasia 2020-05-21 anticipated 100 Complete https://irct.ir/trial/53553 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 100 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Gynecology Clinic of Shahid Beheshti Hospital, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups. 3 Non atypical endometrial hyperplasia. Intervention 1: Intervention group: Isoflavone 50 mg Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months. Intervention 2: Control group: Placebo Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months. 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Zahra Vahedpour
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 zahravahedpoor@gmail.com Kashan University of Medical Sciences scientific Dr. Shirin Tabatabaee
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 tabatabaee.sh@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Women aged 30 to 45 years who are diagnosed with non atypical endometrial hyperplasia 30 years 45 years Female Those taking any hormonal medicine within 6 months prior to enrollment in the study Patients with focal endometrial lesions atypical endometrial hyperplasia Women with congenital uterine anomalies Menopause women Hypersensitivity to soybean products. Unwillingness to cooperate. N85.0 Endometrial hyperplasia Treatment - Drugs Placebo Intervention group: Isoflavone 50 mg Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months. Control group: Placebo Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months. Endometrial histology. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Biopsy. Serum estradiol levels. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Elisa. Drug side-effects. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: questionnaire. Kashan University of Medical Sciences Approved 2020-05-11 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)