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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04831151
Enrollment
42
Registered
2021-04-05
Start date
2021-03-01
Completion date
2023-06-30
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

hirsutism, combined oral contraceptives, amenorrhea

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

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.

Interventions

Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate

DRUGYasmin

Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolomics3 monthsmeasured by H1 nuclear magnetic resonance spectroscopy

Secondary

MeasureTime frameDescription
hirsutism score3 monthsMeasured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome.
fasting serum insulin levels3 monthsmeasured on the 3rd day of menstrual cycle, before before 10 am, after 8-hour-night fasting. The lower levels means better outcome.
low density lipoprotein3 monthsmeasured on the 3rd day of menstrual cycle, before before 10 am, after 8-hour-night fasting. The lower levels means better outcome.
body mass index3 monthsweight and height will be combined to report BMI in kg/m\^2. The lower index means better results.
clinical findings3 monthsRising the number of participants with menstrual periods shorter than 35 days means better outcome.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSenem Arda Düz, Asisstant professor
senem_arda@yahoo.com+905332776401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026