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

Study Overview
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Brief Summary
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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)

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate
* Drug: Metformin 1500mgs per day


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCP<br>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<br> <br> |
| Active Comparator: Metformin<br>Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily. | Drug: Metformin 1500mgs per day<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in Menstrual cycle in women with polycystic ovary syndrome. | 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 | 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 | 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 | Weight loss will be compared between the two arms following 6 months of treatment | 6months | 
| Reduction in total testosterones | Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment. | 6months | 
| Reduction in serum fasting insulin | Reduction in insulin levels following treatment will be compared between the two arms | 6 months | 
| Improvements in lipid profile | 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 | 75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups | 6months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Metformin, OCP, metabolic parameters