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IRCT20181006041252N6 IRCT 2019-01-23 Sabzevar University of Medical Sciences Investigating the effect of levothyroxine therapy on sex hormone levels Investigating the effect of levothyroxine therapy on sex hormone levels in women with subclinical Hypothyroidism. 2019-01-11 anticipated 80 Complete https://irct.ir/trial/36610 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly, 20 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with Levothyroxine and Placebo tablet, respectively. First, we determine all foursome modes in which half of the individuals are assigned to group A and the other half to group B. Then we assign one of the digits 1 to 6 to each of the foursome combinations (which includes six modes). In the next step, we must randomly select 20 blocks of four and write their combinations in succession. For this we have to make 20 samplings with replacement from a six-member community; 20 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block), Blinding description: Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The clinical observant and the participants are unaware of the groups. It should be noted that levothyroxine and placebo tablet have been similar in appearance, color, and packaging. 3 Subclinical hypothyroidism. Intervention 1: Intervention group: Patients in this group are treated with levothyroxine for two months (50 micrograms daily and fasting 5 days a week) with the aim of Euthyroidism. Intervention 2: Control group: Patients in this group are treated with placebo for two months (fasting 5 days a week). 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 No more information
public Dr. Najmeh Rahimi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8337 rahimy.najmeh@gmail.com Sabzevar University of Medical Sciences scientific ِDr. Najmeh Rahimi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8337 rahimy.najmeh@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Women aged 17-40 years with TSH above the maximum normal laboratory range and less than 10 and also T3, T4 normal. 17 years 40 years Female Irregular ovarian cycles (irregular menstruation) Pregnancy, breastfeeding, hypothalamic amenorrhoea, known pituitary diseases, and early menopause. The history of ovarian surgery, polycystic ovary syndrome (PCOS), and the use of hormonal medications. History of levothyroxine tablets in the last two months. Dissatisfaction patients to participate in the study. E02 Subclinical iodine-deficiency hypothyroidism Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group are treated with levothyroxine for two months (50 micrograms daily and fasting 5 days a week) with the aim of Euthyroidism. Control group: Patients in this group are treated with placebo for two months (fasting 5 days a week). Determine the level of Estrogen. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting the intervention. Method of measurement: Use of Luminescence quantitative and ELISA methods. Determine the level of progesterone. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting the intervention. Method of measurement: Use of Luminescence quantitative and ELISA methods. Sabzevar University of Medical Sciences Approved 2019-01-13 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)