The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of the treatment of polycystic ovary syndrome with two different oral contraceptives that contain cyproterone acetate and drospirenone

Detailed Description
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Polycystic ovary syndrome (PCOS), is the most common endocrinological disorder that affects the reproductive aged women. In addition to causing problems such as menstrual irregularity, hirsutism, acne, it is also an important health problem that can cause infertility, insulin resistance, impaired glucose metabolism, diabetes, high blood pressure, heart disease, dyslipidemia in advanced ages. Diagnostic criteria also vary widely in these patients. These patients are often overweight or obese, and abdominal adiposity is common in these patients. The patients also suffer from insulin resistance and hyperinsulinemia in this syndrome. All of this is probably the result of a vicious cycle that starts in the antenatal period. Combined oral contraceptives (COCs), are the first-choice treatment option for many patients by improving both menstrual irregularity, hyperandrogenism, and insulin resistance through sex hormone binding globulin (SHBG). They reduce the risk of endometrial hyperplasia and endometrial cancer by providing regular menstruation. Nowadays, the use of metabolomics is increasing in understanding the pathophysiology of diseases. Metabolomics technology examines low molecular weight substrates used in intracellular enzymatic reactions, intermediates and end products resulting from these reactions. Metabolomic examinations are gaining momentum in terms of understanding the pathophysiology of diseases, especially endometrial cancer and ovarian cancer, in the field of Obstetrics and Gynecology. Metabolomics continue to be investigated in understanding the pathophysiology of PCOS, but there are not enough studies yet on the effects of treatment on the disease in terms of metabolomics.

Official Title
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The Effect of Two Combined Oral Contraceptives Containing Cyproterone Acetate or Drospirenone on Blood Metabolomics in Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Yasmin
* Drug: Diane-35


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are diagnosed with polycystic ovary syndrome according to Rotterdam criteria and who do not have any additional chronic systemic disease Exclusion Criteria: The presence of any diseases that cause hormonal disorders and any chronic systemic diseases, the patients who are already under any treatment for polycystic ovary syndrome

Ages Eligible for Study
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Minimum Age: 15 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: Drospirenone group: 0,03 mg ethinylestradiol + 3 mg drospirenone<br>generic name:yasmin dosage form:oral dosage: 0,03 mg ethinylestradiol + 3 mg drospirenone frequency: once a day duration: 3 months | Drug: Yasmin<br>* Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone<br>|
| Active Comparator: cyproterone acetate group: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate<br>generic name:diane 35 dosage form:oral dosage: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate frequency: once a day duration: 3 months | Drug: Diane-35<br>* Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics | measured by H1 nuclear magnetic resonance spectroscopy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hirsutism score | Measured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome. | 3 months | 
| fasting serum insulin levels | measured on the 3rd day of menstrual cycle, before before 10 am, after 8-hour-night fasting. The lower levels means better outcome. | 3 months | 
| low density lipoprotein | measured on the 3rd day of menstrual cycle, before before 10 am, after 8-hour-night fasting. The lower levels means better outcome. | 3 months | 
| body mass index | weight and height will be combined to report BMI in kg/m^2. The lower index means better results. | 3 months | 
| clinical findings | Rising the number of participants with menstrual periods shorter than 35 days means better outcome. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hirsutism, combined oral contraceptives, amenorrhea