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IRCT20140525017827N8 IRCT 2020-04-10 Shiraz University of Medical Sciences Effect of metformin and simvastatin in treatment of polycystic ovarian syndrome Comparison of metabolic, endocrine, and clinical outcomes of treatment with simvastatin and metformin in women with polycystic ovaries 2020-04-13 anticipated 144 Complete https://irct.ir/trial/46990 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar bottles, Blinding description: Metformin and simvastatin have been administered in the similar bottles, so patients and researchers were unable to detect which one was Metformin or simvastatin . Our nurse colleague in this study in Hafez hospital delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: receive 20 mg of simvastatin every night after dinner. Intervention 2: Intervention group: receive 500 mg of metformin three times daily after meals. Yes - There is a plan to make this available What will be shared: Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient When: Participant data file:2020 Ethic form: 2020 To whom: Participant data file: Researcher & Patient Ethic form: Patient Conditions: Participant data file: participant's or legal guardian's are permitted for awareness of the results. Ethic form: participant's or legal guardian's are permitted for awareness of the results. Where to obtain: Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences How to obtain: Participant data file: Refer to Maternal Fetal medicine Research Center, request for result information. Ethic form: Refer to Maternal Fetal medicine Research Center, request for result information. Comments:
public Maliehe Kamali
Maternal- Fetal Medicine (Perinatology)research center; Hafez Hospital; Chamran Ave.,Shiraz
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 malihe_kamali@yahoo.com Shiraz University of Medical Sciences scientific Nasrin Asadi
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 nsasadi2012@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) oligomenorrhea or amenorrhea clinical or laboratory findings of hyperandrogenism existence of polycystic ovaries in ultrasound examination) will be invited to take part in the study Aging 18-40 years single Not suffering from thyroid disorder, Cushing’s syndrome, and hyperprolactinemia Not having kidney disorder, liver disorder, diabetes, and lipid profile disorder Not having the history of cardiovascular diseases and hypertension Not having used ovarian function stimulators or hormonal drugs during the past 3 months Not having used medications affecting insulin or lipid profiles within the past 3 months Not smoking Not consuming alcohol Not using drugs Not suffering from breast cancer Not having medical contraindications Not having maladaptation 18 years 40 years Female Getting married Not being willing to continue treatment Presentation of side effects due to consumption of study medications Not following the research protocol Losing weight by 3 kg or more within the past 2 months E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: receive 20 mg of simvastatin every night after dinner Intervention group: receive 500 mg of metformin three times daily after meals Endocrine parameters (total testosterone, free testosterone, DHEA, estradiol, FSH, LH, SHBG, prolactin, and TSH). Timepoint: before and after intervention. Method of measurement: Eliza Kit. Metabolic parameters (bilirubin, aminotransferases, total cholesterol, LDL, HDL, TG, fasting glucose, 2-hour glucose tolerance test, fasting insulin, insulin sensitivity index, hs-CRP, sVCAM, and homocysteine). Timepoint: Before and after intervention. Method of measurement: Eliza Kit. Shiraz University of Medical Sciences Approved 2020-01-15 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)