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IRCT201403101836N7 IRCT 2014-04-15 Shahid Sadoughi University of Medical Sciences Evaluation of effectiveness of Metformin and pioglitazone in women with polycystic ovary syndrome Metformin and pioglitazone in women with polycystic ovary syndrome 2014-04-09 anticipated 75 Complete https://irct.ir/trial/1413 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Polycystic ovary syndrome. Intervention 1: group number 1 (25 patient) metformin 500 mg three times a day (first week 500 mg daily then second week 500 mg two times a day and third week 500 mg three times a day and continuous with 500 mg three times a day for three month). Intervention 2: group number 2 (25 patient ) tab pioglitazone 30 mg daily for three month. Intervention 3: group number3 (25 patient) tab metformin 500 mg three times a day (first week 500 mg daily then second week 500 mg two times a day and third week 500 mg three times a day and continuous with 500 mg three times a day for three month ) and tab pioglitazone 30 mg daily.
public Dr Seyed Mojtaba Sohrevardi
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
Yazd Iran (Islamic Republic of) +98 35 1820 3419 smsohrevardi@yahoo.com Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences scientific Dr Seyed Mojtaba Sohrevardi
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
Yazd Iran (Islamic Republic of) +98 35 1820 3419 smsohrevardi@yahoo.com Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age between 18 to 40 years old; diagnosed PCOS by AES (Androgen excess soiciety2006) criteria include: 1. Oligo or anovulation 2. Clinical or biochemical hyperandrogenism and rejection any other reasen cause to hyperandrogenism. Exclusion criteria: pregnancy and lactation; impaired liver and renal function tests; thyroid disorder; hyperprolactinemia; adrenal disorders; patient on estrogen and progesterone pills; the presence of type 1 and type 2 diabetes mellitus; late-onset congenital adrenal hyperplasia, and Cushing’s syndrome; none of the women had been taking clomiphene citrate, oral contraceptives, antiandrogens, insulin, minoxidil, phenytoin, cyclosporine, or drugs to control their appetite, lipid profile, during the previous 3 months and any severe systemic disease. 18 years 40 years Female E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs group number 1 (25 patient) metformin 500 mg three times a day (first week 500 mg daily then second week 500 mg two times a day and third week 500 mg three times a day and continuous with 500 mg three times a day for three month) group number 2 (25 patient ) tab pioglitazone 30 mg daily for three month group number3 (25 patient) tab metformin 500 mg three times a day (first week 500 mg daily then second week 500 mg two times a day and third week 500 mg three times a day and continuous with 500 mg three times a day for three month ) and tab pioglitazone 30 mg daily Serum Insulin level. Timepoint: before intervention and after intervention( after three month). Method of measurement: mili IU per liter. Low density lipoprotein. Timepoint: before intervention and after intervention( after three month). Method of measurement: mili gram per deciliter. High density lipoprotein. Timepoint: before intervention and after intervention( after three month). Method of measurement: mili gram per deciliter. Triglyceride. Timepoint: before intervention and after intervention( after three month). Method of measurement: mililgram per deciliter. Fast blood suger. Timepoint: before intervention and after intervention ( after three month). Method of measurement: milligram per deciliter. Dehydroepiandrosterone sulphate. Timepoint: before intervention and after intervention( after three month). Method of measurement: milligram per liter. 17hydroxyprogestrone. Timepoint: before intervention and after intervention( after three month). Method of measurement: microgram per liter. Total Testosterone. Timepoint: before intervention and after intervention( after three month). Method of measurement: microgram per liter. LH/FSH ratio. Timepoint: before intervention and after intervention( after three month). Method of measurement: IU per liter. Cholesterol. Timepoint: before intervention and after intervention( after three month). Method of measurement: milligram per deciliter. Waist to hip ratio. Timepoint: before intervention and after intervention after three month. Method of measurement: meter. Body Mass Index. Timepoint: before intervention and after intervention after three month. Method of measurement: kilogram per square meter. Side effect of dugs. Timepoint: afer intervention (after three month). Method of measurement: descriptive. Homeostatic Model Assessment-Insulin Resistance) HOMA -IR). Timepoint: before intervention and after intervention( after three month). Method of measurement: milli IU per deciliter /milli gram per deciliter. Shahid Sadoughi University of Medical Sciences Approved 2014-03-09 Shahid Sadoughi University of Medical Sciences Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd Yazd Iran (Islamic Republic of)