Trial | NCT02744131  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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)
Study Started
May 31
2016
Primary Completion
Sep 30
2018
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Feb 05
2018

Drug Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

Drug Metformin 1500mgs per day

OCP Active Comparator

Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.

Metformin Active Comparator

Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.

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 .
No Results Posted