Polycystic Ovary Syndrome Clinical Trial
Official title:
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
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)
n/a
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