OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kar Clinic & Hospital Pvt. Ltd.
• Collaborators: All India Institute of Medical Sciences, New Delhi; Dr Patil's Fertility & Endoscopy Clinic, Bangalore; Nova IVI Fertility, New Delhi; Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur; University of Messina
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Cyproterone; Cyproterone Acetate; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Metformin; Polyestradiol phosphate

Criteria

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 .