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IRCT20110523006563N3 IRCT 2018-01-04 Vice chancellor for Research,Tabriz University Of Medical Sciences comparative study of natural micronized progestrone and gonadotropin-releasing hormone agonist in the control of bleeding during hysterescopic myomectomy in women with abnormal uterine bleeding comparative study of natural micronized progestrone and gonadotropin-releasing hormone agonist in the control of bleeding during hysterescopic myomectomy in women with abnormal uterine bleeding 2018-01-10 anticipated 50 Complete https://irct.ir/trial/7007 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Patients will randomly be divided into two groups using the Randlist version 1, 2, Dattng CmbH, Tubingen Germany software, Blinding description: Random selection will be done by a nurse, that aware of the details of an investigation. Doctors and patients to selected groups will be blind. 1-2 Abnormal uterine and vaginal bleeding. Intervention 1: Intervention group 1 : A 100 mg capsule of natural micronized progesterone called Utrogestan will be used, starting from the first day of the period for 30 days, two capsules of 200 mg will be used at bedtime with 3 hours from the last meal with a glass of water. Intervention 2: Intervention group 2: Intramuscular injection of 3.75 mg of diafililic ampoule as a GnRH agonist compound will be used on day 21 of the period two dose intervals of 28 days for 2 months prior to the hysteroscopy. 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 After the study is completed, it will be decided
public Mehri Jaefari Shobeiri
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahhroudin@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) Patients with abnormal uterine bleeding Patients with submucosal myoma with a diameter of 30 mm or less and zero or first grade no limit no limit Female : Patients with a history of heart disease; Hepatic; Diabetes; Thromboembolism; Cancer of the uterus and cervix; Submucosal leiomyoma larger than 3 cm; Uterine septum; pregnant women; Severe bleeding; Anti coagulation therapy ICD-10 Other abnormal uterine and vaginal bleeding Treatment - Drugs Treatment - Drugs Intervention group 1 : A 100 mg capsule of natural micronized progesterone called Utrogestan will be used, starting from the first day of the period for 30 days, two capsules of 200 mg will be used at bedtime with 3 hours from the last meal with a glass of water. Intervention group 2: Intramuscular injection of 3.75 mg of diafililic ampoule as a GnRH agonist compound will be used on day 21 of the period two dose intervals of 28 days for 2 months prior to the hysteroscopy. The hemoglobin concentration. Timepoint: Six hours after surgery. Method of measurement: Blood test. Duration of surgery. Timepoint: After surgery. Method of measurement: Questionnaire. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2017-11-14 Ethics Committee Of Tabriz University Of Medical Sciences. Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)