Spots Global Cancer Trial Database for OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women

Study Description

Brief Summary: Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E\&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India. Intervention: Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar \& 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays) Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)

Detailed Description:

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Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: No

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