Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Last updated: November 28, 2018
Sponsor: Dow University of Health Sciences
Overall Status: Active - Recruiting

Phase

1/2

Condition

Testotoxikose

Testotoxicosis

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT03757923
DowUHS3
  • Ages 18-40
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. women of age 18-40 with primary or secondary infertility.

  2. Polycystic ovarian syndrome daignosed using rotterdam criteria.

  3. Not taken any medication before for PCOS.

Exclusion

Exclusion Criteria:

  1. Women having type 1 or type 2 diabetes mellitus.

  2. Abnormal kidney or liver function.

  3. Hypertension or heart disease.

  4. Gonadotrophin induction or ovarian drilling before will not be included in this study.

Study Design

Total Participants: 110
Study Start date:
June 18, 2018
Estimated Completion Date:
January 31, 2019

Study Description

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.

Connect with a study center

  • Dow University Hospital OJHA

    Karachi, Sindh 75270
    Pakistan

    Active - Recruiting

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