The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Drospirenone group: 0,03 mg ethinylestradiol + 3 mg drospirenone generic name:yasmin dosage form:oral dosage: 0,03 mg ethinylestradiol + 3 mg drospirenone frequency: once a day duration: 3 months |
Drug: Yasmin
Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone
|
| Active Comparator: cyproterone acetate group: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate 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
Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate
|
Outcome Measures
Primary Outcome Measures
- Metabolomics [3 months]
measured by H1 nuclear magnetic resonance spectroscopy
Secondary Outcome Measures
- hirsutism score [3 months]
Measured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome.
- fasting serum insulin levels [3 months]
measured on the 3rd day of menstrual cycle, before before 10 am, after 8-hour-night fasting. The lower levels means better outcome.
- low density lipoprotein [3 months]
measured on the 3rd day of menstrual cycle, before before 10 am, after 8-hour-night fasting. The lower levels means better outcome.
- body mass index [3 months]
weight and height will be combined to report BMI in kg/m^2. The lower index means better results.
- clinical findings [3 months]
Rising the number of participants with menstrual periods shorter than 35 days means better outcome.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inonu University | Malatya | Turkey | 44280 |
Sponsors and Collaborators
- Inonu University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/28