Hyperandrogenism Clinical Trial
Official title:
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
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.
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