To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.
This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi. The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia. Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
INSULIN SENSITIZING AGENTS
INSULIN SENSITIZING AGENT
Dow University Hospital OJHA
Karachi, Sindh, Pakistan
RECRUITINGHIRSUTISM
Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
Time frame: 3 months
POLYCYSTIC OVARIES
assessment on ultrasound (qualitative-present/not present)
Time frame: 3 months
MENSTRUAL IRREGULARITIES
assessment on history(qualitative-present/not present)
Time frame: 3 months
BMI
weight and height will be combined to report BMI in kg/m2
Time frame: 3 months
SERUM FASTING INSULIN
unit of measure: uIU/ml
Time frame: 3 months
FASTING BLOOD SUGAR
unit of measure:mg/dl
Time frame: 3 months
FREE TESTOSTERONE
unit of measure :nmol/l
Time frame: 3 months
FREE ANDROGEN INDEX
numerical
Time frame: 3 months
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