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IRCT20201227049847N1 IRCT 2021-01-09 Homa Pharmed Company Efficacy and safety of Diphereline and Microreline 3.75mg in breast cancer patients Comparison of efficacy and safety of Diphereline 11.25 mg, Microreline 11.25 mg, and Microreline 3.75mg in premenopausal breast cancer patients 2019-04-04 anticipated 210 Complete https://irct.ir/trial/53268 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After enrolling subjects in the study, they will assign one of the three study groups using the random six-block method. Before the intervention, a statistician prepared 35 sets of BBCAAC, BCAACB, CCAABB, etc., modes using MS Excel. The letters A, B, and C will be each symbol of one of the study groups by using the draw. Each code of six will be enclosed in a sealed envelope that cannot be read from the envelope. When the patients are visited, one of the envelopes will be randomly selected, and on the order of the letters mentioned in it, the patients will be assigned to one of the study arms, Blinding description: Since the randomization will be done by the relevant person in charge of the clinic, and the recording of the tests and complications will be done by a follow-up physician, in quarterly drug injection groups, the subjects, the observer (oncologist and nurse), and the analyzer will not know the type of drug. In the one-month injection group, it will not be possible to blind the subject and the observer. 3 Breast Cancer. Intervention 1: The first intervention group: Diphereline 11.25 mg, manufactured by Ipsen France, will be given to patients every three months for one year. Intervention 2: The second intervention group: Microreline 11.25 mg, manufactured by Homa Pharmed Iran, will be given to patients every three months for one year. Intervention 3: The third intervention group: Microreline 3.75 mg, manufactured by Homa Pharmed Iran, will be given to patients monthly for one year. 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 There is no further information
public Safa Najjar Najafi
No.146, South Gandi Ave, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8887 6869 safa3n@yahoo.com Iranian academic center for education culture and research scientific Shahpar Haghighat
No.146, South Gandi Ave, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8887 6869 sha_haghighat@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) Age over 18 years Positive estrogen and progesterone receptor Premenopausal patients Perimenopausal patients, if they have the same estradiol levels as premenopausal women. 18 years no limit Female Existence of metastasis History of hysterectomy and oophorectomy C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: Diphereline 11.25 mg, manufactured by Ipsen France, will be given to patients every three months for one year. The second intervention group: Microreline 11.25 mg, manufactured by Homa Pharmed Iran, will be given to patients every three months for one year. The third intervention group: Microreline 3.75 mg, manufactured by Homa Pharmed Iran, will be given to patients monthly for one year. Changes in Estradiol level over one year. Timepoint: Before the intervention, 3, 6 and 12 months after the intervention. Method of measurement: Blood test. Menopausal symptoms. Timepoint: Before the intervention, three, six, nine and twelve months after the intervention. Method of measurement: Menopause Rating Scale. Drug side effects. Timepoint: Before the intervention, three, six, nine and twelve months after the intervention. Method of measurement: Drug side effects checklist. Homa Pharmed Company Approved 2018-07-22 Motamed Cancer Institute- Academic Center for Education, Culture and Research No.146, South Gandi Ave, Vanak Sq, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)