OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement in acne score
Study Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 40 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PCOS Women diagnosed by Rotterdam criteria
- •Age > 16 or menarche of at least 2 yr upto age
- •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 .
Arms & Interventions
Metformin
Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.
Intervention: Metformin 1500mgs per day (Drug)
OCP
Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.
Intervention: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate (Drug)
Outcomes
Primary Outcomes
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.
Reduction in serum fasting insulin
Time Frame: 6 months
Reduction in insulin levels following treatment will be compared between the two arms
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
Weight loss following treatment
Time Frame: 6months
Weight loss will be compared between the two arms following 6 months of treatment
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.
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.
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
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.
Secondary Outcomes
No secondary outcomes reported