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

February 1, 2018 updated by: Kar Clinic & Hospital Pvt. Ltd.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OCP
Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.
Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate
Active Comparator: Metformin
Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.
Drug: Metformin 1500mgs per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in Menstrual cycle in women with polycystic ovary syndrome.
Time Frame: Six months
To compare improvement in Menstrual cycle. Women will be required to maintain a menstrual calendar for the duration of the study and asked to fill a questionnaire before and after study duration.The questionnaire will cover menstrual cycle dates, duration and amount. Interpreting the answered will help in assessing improvement in menstrual pattern.
Six months
Improvement in hirsutism
Time Frame: six months
FG scores before and after treatment will be compared between the two arms. Modified Ferriman and Gallwey visual score will be used by a nurse to assess before and after the study period.
six months
Improvement in acne score
Time Frame: Six months
Acne scores before and after treatment will be compared between the two arms. Visual assessment of acne using "mild/moderate/severe " grades will be assessed before and after study by a physician.
Six months
Weight loss following treatment
Time Frame: 6months
Weight loss will be compared between the two arms following 6 months of treatment
6months
Reduction in total testosterones
Time Frame: 6months
Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.
6months
Reduction in serum fasting insulin
Time Frame: 6 months
Reduction in insulin levels following treatment will be compared between the two arms
6 months
Improvements in lipid profile
Time Frame: 6months
Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment
6months
Improvement in glucose tolerance
Time Frame: 6months
75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kar Clinic & Hospital Pvt. Ltd.

Collaborators

All India Institute of Medical Sciences, New Delhi
University of Messina
Nova IVI Fertility, New Delhi
Dr Patil's Fertility & Endoscopy Clinic, Bangalore
Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCP-MET-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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