OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

Study Overview
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Brief Summary
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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.

Official Title
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Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome

Conditions
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PCOS

Intervention / Treatment
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* Drug: Ethinyl Estradiol-cyprosterone acetate
* Drug: Metformin Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with PCOS according to the Rotterdam criteria Exclusion Criteria: Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. Medical or surgical treatment of PCOS during the previous 3 months Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months) Inability to understand the proposal of the study precluding effective informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Metformin<br>Metformin 500mg bid in morning and evening after meals to be taken for 6 months. | Drug: Metformin Hydrochloride<br>* Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.<br>|
| Active Comparator: OCP<br>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. | Drug: Ethinyl Estradiol-cyprosterone acetate<br>* Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |