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IRCT20140111016161N7 IRCT 2018-08-03 Tehran University of Medical Sciences Medroxyprogesterone acetate and dydrogesterone effect in the treatment of uterine bleeding Comparison of medroxyprogesterone acetate and dydrogesterone effects on treatment of patients with abnormal vaginal bleeding 2017-03-21 anticipated 176 Complete https://irct.ir/trial/15214 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our sample size is 176 people, with 88 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 4, Blinding description: The random allocation list will solely available to the epidemiologist. 176 cards containing sequences of treatments will be written and be placed inside sealed envelopes. A10-digit random code, as the patient’s identification number, will be provided for each packet. When the physician announces the eligibility of a patient, the methodologist will provide the physician with the envelope. None of the patients should be aware of the type and process of treatment. Also, the person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed. 3 vaginal bleeding. Intervention 1: First group: treated with oral medroxyprogesterone acetate tablets, 5 mg every 12 hours from 14th day of menstruation for 10 days. Treatment will continue for 3 months. Intervention 2: Second group: treated with oral dydrogesterone tablets, 10 mg every 12 hours from 14th day of menstruation for 10 days. Treatment will continue 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 The research team has not yet made a decision on how to publish the results or the statistical analysis map.
public Newsha Mohamad Nejad
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 newsha1367@yahoo.com Tehran University of Medical Sciences scientific Dr Reihane hoseini
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 rayh_h@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Endometrial thickness greater than 5 mm Simple endometrial hyperplasia 30 years 45 years Female Endocrine disorders Anatomical problems; History of hormone therapy History of coagulopathy Contraindication for progestin therapy N93 Other abnormal uterine and vaginal bleeding Treatment - Drugs Treatment - Drugs First group: treated with oral medroxyprogesterone acetate tablets, 5 mg every 12 hours from 14th day of menstruation for 10 days. Treatment will continue for 3 months. Second group: treated with oral dydrogesterone tablets, 10 mg every 12 hours from 14th day of menstruation for 10 days. Treatment will continue for 3 months. Vaginal bleeding. Timepoint: At the beginning of the study (before the intervention) and 3 and 6 months after starting the intervention. Method of measurement: Standard check list designed by the research team. Endometrium thickness. Timepoint: At the beginning of the study (before the intervention) and 3 and 6 months after starting the intervention. Method of measurement: sonography. Side effects of treatments. Timepoint: At the beginning of the study (before the intervention) and 3 and 6 months after starting the intervention. Method of measurement: Standard check list designed by the research team. Tehran University of Medical Sciences Approved 2016-12-23 Tehran University of Medical Sciences , Deputy of Research Qods St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)