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IRCT20230930059567N1 IRCT 2023-11-11 Karaj University of Medical Sciences Comparison of the effect of low dose Megestrol (40 mg) and Medroxyprogesterone 10 mg on the quality of life in menopausal women. Comparison of the effect of low dose Megestrol (40 mg) and Medroxyprogesterone 10 mg on the quality of life in menopausal women. 2023-11-22 anticipated 80 Complete https://irct.ir/trial/72888 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 1. Randomization method: Blocked 2. Randomization unit: Individual 3. Randomization Tool : A randomization list is generated using a web-based software (https://www.sealedenvelope.com/simple-randomiser/v1/lists), which is only accessible to a researcher who is not involved in assigning or evaluating the outcomes. At the time of identifying each sample, the allocation group of the patient is announced according to the list through this researcher. 4. Method of generating the random sequence: A randomization list is prepared using a web-based software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The block sizes of 2, 4, and 6 are considered. 5. Explanation of allocation concealment: By considering non-homogeneous block sizes, the allocation sequence will be concealed. In addition, a randomization list is generated, which is only available to a researcher who is not involved in assigning or evaluating the outcomes, Blinding description: The study is conducted in a triple-blind manner. In this type of blinding, the data analyst will not be aware of the treatment group allocation. The data related to the received treatment will be entered into the SPSS software as groups 1 and 2. The outcome assessor will also be unaware of the treatment group allocation. To blind the participants, medications will be given to patients in similar containers. 3 Menopause symptoms. Intervention 1: Intervention group: Megestrol Acetate, C24H32O4, 40 milligrams, one tablet per day, for one month, accompanied by a glass of water. Intervention 2: Intervention group : Medroxyprogesterone Acetate, C22H32O3, 10 milligrams, one tablet every 12 hours for one month, accompanied by a glass of water. 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 Samira Abdollahi
Alborz University of Medical Sciences, Administrative Town, North Taleghani Blvd , Taleghani Square, Karaj.
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 samiraabdollahi66@yahoo.com Karaj University of Medical Sciences scientific Samira Abdollahi
Alborz University of Medical Sciences, Administrative Town, North Taleghani Blvd, Taleghani Square, Karaj.
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 samiraabdollahi66@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Iranian women aged 45 to 55 year‌. FSH serum level greater than or equal to 40-20 mm units per milliliter (pre menopausal) Do not have a physical or mental illness . Do not have addiction or use of hookah cigarettes or alcohol. The person's body mass index should be less than or equal to 29. 45 years 55 years Female N95 Menopausal and other perimenopausal disorders Other Other Intervention group: Megestrol Acetate, C24H32O4, 40 milligrams, one tablet per day, for one month, accompanied by a glass of water. Intervention group : Medroxyprogesterone Acetate, C22H32O3, 10 milligrams, one tablet every 12 hours for one month, accompanied by a glass of water. Quality of life score in menqol questionnaire. Timepoint: Measuring the quality of life during the study and 1 month after Megestrol consumption. Method of measurement: Menopausal Women's Quality of Life Questionnaire - Persian version (Menqol). Quality of life score in menqol questionnaire. Timepoint: Measuring the quality of life during the study and 1 month after Medroxyprogestrone consumption. Method of measurement: Menopausal Women's Quality of Life Questionnaire - Persian version (Menqol). Karaj University of Medical Sciences Approved 2023-07-29 Ethics committee of Alborz University of Medical Sciences Alborz University of Medical Sciences , Administrative Town , North Taleghani Blvd , Taleghani Square, Karaj. Karaj Alborz Iran (Islamic Republic of)