OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
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)
Inclusion Criteria:

 -  PCOS Women diagnosed by Rotterdam criteria

 -  Age > 16 or menarche of at least 2 yr upto age 40.

 -  Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl
 ovarian volume ≥ 10 cc BMI>23

 -  Women not attempting pregnancy at present.

 Exclusion Criteria:

 -  PCOS Women with BMI ≤ 23

 -  Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic

 -  Known diabetic or hypertension .