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

Kar Clinic & Hospital Pvt. Ltd.

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin 1500mgs per day; Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02744131

OCP-MET-2016

Details and patient eligibility

About

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)

Enrollment: 100 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

OCP

Active Comparator group

Description:

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

Treatment:

Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

Metformin

Active Comparator group

Description:

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

Treatment:

Drug: Metformin 1500mgs per day