Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Conditions
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Menstrual Irregularities, Hyperandrogenism

Intervention / Treatment
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* Drug: TAB METFORMIN
* Drug: TAB PIOGLITAZONE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women of age 18-40 with primary or secondary infertility. Polycystic ovarian syndrome daignosed using rotterdam criteria. Not taken any medication before for PCOS. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trail
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin<br>TAB METFORMIN 500mg TDS | Drug: TAB METFORMIN<br>* INSULIN SENSITIZING AGENTS<br>|
| Experimental: pioglitazone<br>TAB PIOGLITAZONE 30 mg OD | Drug: TAB PIOGLITAZONE<br>* INSULIN SENSITIZING AGENT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIRSUTISM | Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative) | 3 months | 
| POLYCYSTIC OVARIES | assessment on ultrasound (qualitative-present/not present) | 3 months | 
| MENSTRUAL IRREGULARITIES | assessment on history(qualitative-present/not present) | 3 months | 
| BMI | weight and height will be combined to report BMI in kg/m2 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SERUM FASTING INSULIN | unit of measure: uIU/ml | 3 months | 
| FASTING BLOOD SUGAR | unit of measure:mg/dl | 3 months | 
| FREE TESTOSTERONE | unit of measure :nmol/l | 3 months | 
| FREE ANDROGEN INDEX | numerical | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCO, Metformin