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IRCT20110523006563N4 IRCT 2020-11-26 Tabriz University of Medical Sciences Comparative study of dienogest and danazol in endometrial preparation Comparative study of dienogest and danazol in endometrial preparation for hysteroscopic myomectomy in patients with intrauterine myoms 2020-09-22 anticipated 60 Complete https://irct.ir/trial/52004 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups using Randlist version 1.2 Dattng GmbH, Tubingen Germany with the code 351656064, Blinding description: Surgeon and operating room nurse are blinded. Patients do not have any medical intervention during surgery and entering the operating room. Patients' medication information will not be provided to the surgeon and the surgeon and operating room nurse will be unaware of the medication received. 3 Intrauterine myoma. Intervention 1: Intervention group: Dienogest 2 mg tablets will be used for up to 4 weeks from the first day of menstruation. Dienogest is prepared under the brand name of Dinovel in the form of 2 mg tablets made by Chemo, Spain by order of Iran Hormone Pharmaceutical Company. Intervention 2: Intervention group: Danazole 200 mg tablets will be used from the first day of the period, one morning pill and one evening pill for up to 4 weeks. Danazole is available in the form of 200 mg tablets made by Cipla, India by order of Kimia Ara Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Mehri Jaefari Shobeiri
Tabriz University Of Medical Sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Mehri Jaefari Shobeiri
Tabriz University Of Medical Sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Reproductive ages Moderate to moderate abnormal uterine bleeding Do not receive hormonal medication for 8 weeks Submucosal myoma 30 mm or less in diameter in transvaginal ultrasound Submucosal myoma grade zero or I according to the classification of the European Society of Endoscopy and Gynecology no limit no limit Female Cardiovascular disease Hepatic disease Renal disease Pulmonary disease Hematologic disease Hypertension Diabetes High triglyceride Thromboembolism History of uterine and cervical cancer History of submucosal leiomyoma larger than 3 cm History of acute genital infection History of the uterine septum Pregnancy Infertility Requires transfusion Severe bleeding Using anticoagulants D25.9 Leiomyoma of uterus, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Dienogest 2 mg tablets will be used for up to 4 weeks from the first day of menstruation. Dienogest is prepared under the brand name of Dinovel in the form of 2 mg tablets made by Chemo, Spain by order of Iran Hormone Pharmaceutical Company. Intervention group: Danazole 200 mg tablets will be used from the first day of the period, one morning pill and one evening pill for up to 4 weeks. Danazole is available in the form of 200 mg tablets made by Cipla, India by order of Kimia Ara Pharmaceutical Company. Endometrial atrophy. Timepoint: 4 weeks after the intervention. Method of measurement: Vaginal ultrasound. Bleeding during surgery. Timepoint: After surgery. Method of measurement: Operating room suction. Clear image resolution. Timepoint: During surgery. Method of measurement: Observed by a gynecological surgeon. Operation duration. Timepoint: During surgery. Method of measurement: Observed by a gynecological surgeon. Success rate of myomectomy. Timepoint: During surgery. Method of measurement: Observed by a gynecological surgeon. Tabriz University of Medical Sciences Approved 2020-10-12 Ethics Committee Of Tabriz University Of Medical Sciences. Third Floor, Number 2 central building, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)