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This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin 500mg bid in morning and evening after meals to be taken for 6 months. |
|
| OCP | Active Comparator | OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinyl Estradiol-cyprosterone acetate | Drug | Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ovarian stromal blood flow by using Doppler | By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI as measured in kg/m2 | 6 months | |
| Improvement in hirsutism measured by Modified Ferriman and Gallwey scores | 6 months | |
| Improvement in menstrual cycle pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priyadarshini Tripathy, MD | SCB Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCB Medical College | Cuttack | Odisha | 753007 | India |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin Hydrochloride | Drug | Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants. |
|
| 6 months |
| Change in waist circumference (cm) | 6 months |
| Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml) | 6 months |
| Change in blood level of Testosterone (nmol/L) | 6 months |
| Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml) | 6 months |
| Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl) | 6 months |
| Changes in fasting serum insulin levels (mIU/L) | 6 months |
| Changes in fasting serum glucose levels (mg/dL) | 6 months |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 6 months |