NCT04831151

The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Inonu University · Academic / Other
• Sex: Female
• Age: 15 Years – 35 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Yasmin	Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone
DRUG	Diane-35	Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2021-04-05
• Last updated: 2022-05-19

Locations

1 site across 1 country: Turkey (Türkiye)