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IRCT20170917036227N4 IRCT 2019-06-02 Tehran University of Medical Sciences Effect of cabergoline in treatment of uterine myoma Effect of cabergoline on myoma size and uterine bleeding in women with myomas attending to Arash Hospital 2019-04-02 anticipated 50 Complete https://irct.ir/trial/32502 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be designed by an epidemiologist using STATA version 13 software. The number of blocks considered will be 4, Blinding description: The randomization list will be solely available to the epidemiologist. To hide the random allocation process, 50 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the methodologist will provide the envelope and the type of treatment will be selected based on the type mentioned in the envelope. None of the patients should be aware of the type of treatment they are assigned to. The person who will evaluate the outcomes will be unaware of the random allocation process and type of treatments. Data analysis will be done by a statistician who is unaware of all processes performed. 3 leiomyoma. Intervention 1: Intervention group: 0.5 mg cabergoline tablet (weekly orally, 0.5mg Dostinex tablets per week made in Italy with a generic code of 00562 for 3 months). Intervention 2: Control group: Placebo (composed of sugar and starch, in terms of shape, size and color, quite similar to cabergoline: weekly one, orally). No - There is not a plan to make this available Justification or reason for not sharing IPD is Because we have plan to use our data in another studies, we are not interested to sharing the data at this time
public Dr Marzieh Vahid Dastjerdi
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 mvahid@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Marzieh Vahid-Dastjerdi
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 mvahid@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Uterin bleeding and pelvic pain The size of the leiomyoma is between 3 and 8 cm Aged between 20-50 years 20 years 50 years Female Post menopause Pedunculated myoma Use of Hormonal or lipid-lowering agents during the last 6 months History of cardiovascular disease, venous thromboembolism, diabetes mellitus, liver and kidney disorders, hypertension Other malignancies Need or desire for lyomioma surgery in the next 3 months Pregnancy and lactation Uncontrolled hypertension D25 Leiomyoma of uterus Treatment - Drugs Placebo Intervention group: 0.5 mg cabergoline tablet (weekly orally, 0.5mg Dostinex tablets per week made in Italy with a generic code of 00562 for 3 months) Control group: Placebo (composed of sugar and starch, in terms of shape, size and color, quite similar to cabergoline: weekly one, orally) The size of leiomyoma. Timepoint: Before and 3 month after intervention. Method of measurement: Ulthrasonography. Uterine bleeding. Timepoint: Before and 3 month after intervention. Method of measurement: The number of bleeding days as well as the number of pads used. Side effects of medication. Timepoint: Before and 3 month after intervention. Method of measurement: check list. Tehran University of Medical Sciences Approved 2018-07-25 Ethics committee of Tehran university of medical sciences Zarafshan street, Qods town, Tehran Tehran Tehran Iran (Islamic Republic of)