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

NCT02744131 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-02-05

No results posted yet for this study

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)

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

DRUG

Metformin 1500mgs per day

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Nova IVI Fertility, New Delhi

    collaborator UNKNOWN

  • Dr Patil's Fertility & Endoscopy Clinic, Bangalore

    collaborator UNKNOWN

  • Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur

    collaborator UNKNOWN

  • University of Messina

    collaborator OTHER

  • Kar Clinic & Hospital Pvt. Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-09-30
Completion
2019-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744131 on ClinicalTrials.gov