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临床试验/NCT03757923
NCT03757923Unknown1 期

Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
110
试验地点
1
主要终点
HIRSUTISM

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women of age 18-40 with primary or secondary infertility.
  • Polycystic ovarian syndrome daignosed using rotterdam criteria.
  • Not taken any medication before for PCOS.

排除标准

  • Women having type 1 or type 2 diabetes mellitus.
  • Abnormal kidney or liver function.
  • Hypertension or heart disease.
  • Gonadotrophin induction or ovarian drilling before will not be included in this study.

研究组 & 干预措施

metformin

Experimental

TAB METFORMIN 500mg TDS

干预措施: TAB METFORMIN (Drug)

pioglitazone

Experimental

TAB PIOGLITAZONE 30 mg OD

干预措施: TAB PIOGLITAZONE (Drug)

结局指标

主要结局

HIRSUTISM

时间窗: 3 months

Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)

POLYCYSTIC OVARIES

时间窗: 3 months

assessment on ultrasound (qualitative-present/not present)

MENSTRUAL IRREGULARITIES

时间窗: 3 months

assessment on history(qualitative-present/not present)

BMI

时间窗: 3 months

weight and height will be combined to report BMI in kg/m2

次要结局

  • FREE TESTOSTERONE(3 months)
  • FREE ANDROGEN INDEX(3 months)
  • SERUM FASTING INSULIN(3 months)
  • FASTING BLOOD SUGAR(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jahan Ara Ainuddin

Professor

Dow University of Health Sciences

研究点 (1)

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