An interventional study of Yasmin and Diane-35 in Polycystic Ovary Syndrome, sponsored by Inonu University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by Inonu University · Not applicable, Interventional, and Treatment
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
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.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's planned enrollment of 42 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Inonu University is the lead sponsor of 384 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
generic name:yasmin dosage form:oral dosage: 0,03 mg ethinylestradiol + 3 mg drospirenone frequency: once a day duration: 3 months
Drug: Yasmin
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
Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone
Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate
Metabolomics
measured by H1 nuclear magnetic resonance spectroscopy
Time frame: 3 months
hirsutism score
Measured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
body mass index
weight and height will be combined to report BMI in kg/m\^2. The lower index means better results.
Time frame: 3 months
clinical findings
Rising the number of participants with menstrual periods shorter than 35 days means better outcome.
Time frame: 3 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Drospirenone and ethinyl estradiol combination