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IRCT20100706004329N7 IRCT 2018-10-07 Tehran University of Medical Sciences Effect of Metformin on Breast Fibroadenoma Evaluation of the Effect of Metformin on Breast Fibroadenoma 2018-09-23 anticipated 206 Complete https://irct.ir/trial/33473 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use the blocked randomization method by using a web-based random number generator at www.sealedenvelope.com. Blocks size are considered to be 6, Blinding description: The random allocation list will be provided exclusively to the epidemiologist. To conceal the random allocation process, 206 drugs envelopes with the same shape will be numbered with a 10-digit random code, which is the drug identification number. The code recognition key will be only available to the methodologist. All envelopes will be placed in a box in the order and on the basis of the random allocation list and will be available to the corresponding member. When the breast surgeon declares the patient's eligibility, the methodologist will provide the doctor with the envelope. The treatment plan will be selected based on the type of treatment mentioned in the envelope. None of the patients would be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is a third party who is unaware of the random allocation process and the type of treatment. The statistician who will analyze the data will be unaware of the type of intervention performed. 3 fibroadenoma of breast. Intervention 1: Intervention group: Consumption of 500 mg oral Metformin tablets twice a day for 6 months. Intervention 2: Control group: Consumption of oral placebo tablets (that are completely similar to the metformin tablets) twice a day for 6 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 taken a decision on how to publish the data.
public Dr Sadaf Alipour
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 7788 3283 salipour@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Sadaf Alipour
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 7788 3283 salipour@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Aged between 18 and 50 years old Unilateral or bilateral fibroadenoma of the breast smaller than 3 cm in size, detected by examination and ultrasound. (Diagnostic criteria: 1. in patients under the age of 40 years and patients with masses smaller than 2 cm, the diagnosis will be based on the typical examination and ultrasonographic scan. 2. in patients over 40 years with any size of the mass and patients with masses above 2 cm, the diagnosis will be based on a typical examination, ultrasonographic scan, and pathological investigation of the mass. 18 years 50 years Female Menopause Body mass index greater than 29.9 kg / m2 Use of hormonal medications (such as estrogen, progesterone, GnRH agonist, GnRH antagonist, clomiphene, tamoxifen, letrozole, danazol, contraceptive pills, progesterone IUDs, DHEA) and drugs that affect metabolic status, such as weight, glucose, and lipid-lowering agents Regular consumption of nutritional, medicinal and herbal supplements (such as phytoestrogenic plant compounds, vitamin-rich foods, minerals such as zinc, calcium and ..., multivitamins, vitamins A, E, D, inositol, omega-3, 6) Breast cancer or history of breast cancer A family history of breast cancer in first-degree relatives Hormonal disorders and metabolic diseases such as hypo or hyperthyroidism, metabolic syndrome, diabetes, severe hyperlipidemia - galactorrhea and the pituitary microadenoma Proven or suspected pregnancy and lactation during the intervention Other medical conditions, such as cardiovascular disease, epilepsy, renal or hepatic disorders Contraindications for metformin use (such as hypersensitivity to biguanides, acidemia, heart disease, alcohol consumption, gastroparesis, hepatic disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairments) History of unwanted and intolerable side effects of metformin (such as abdominal pain, chest pain, chills, cholestasis, diarrhea, dizziness, increased liver enzymes, severe headache, hepatitis, hypoglycemia, megaloblastic anemia, myalgia, nausea, Palpitations, rash, rash, vomiting) D24 Benign neoplasm of breast Treatment - Drugs Placebo Intervention group: Consumption of 500 mg oral Metformin tablets twice a day for 6 months. Control group: Consumption of oral placebo tablets (that are completely similar to the metformin tablets) twice a day for 6 months. Size of the Fibroadenoma. Timepoint: At the beginning of the study (before the intervention) and 6 months after starting the intervention. Method of measurement: sonography. Tehran University of Medical Sciences Approved 2018-08-18 Ethics Committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)