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The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics

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ClinicalTrials.gov Identifier: NCT04831151
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Senem Arda Düz, Inonu University

Study Description
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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
Polycystic Ovary Syndrome Drug: Yasmin Drug: Diane-35 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Two Combined Oral Contraceptives Containing Cyproterone Acetate or Drospirenone on Blood Metabolomics in Women With Polycystic Ovary Syndrome
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Metabolomics [ Time Frame: 3 months ]
    measured by H1 nuclear magnetic resonance spectroscopy


Secondary Outcome Measures :
  1. hirsutism score [ Time Frame: 3 months ]
    Measured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome.

  2. fasting serum insulin levels [ Time Frame: 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.

  3. low density lipoprotein [ Time Frame: 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.

  4. body mass index [ Time Frame: 3 months ]
    weight and height will be combined to report BMI in kg/m^2. The lower index means better results.

  5. clinical findings [ Time Frame: 3 months ]
    Rising the number of participants with menstrual periods shorter than 35 days means better outcome.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831151


Contacts
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Contact: Senem Arda Düz, Asisstant professor +905332776401 senem_arda@yahoo.com

Locations
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Turkey
Inonu University Recruiting
Malatya, Turkey, 44280
Contact: Senem Arda Düz, Assistant Professor    +905332776401    senem_arda@yahoo.com   
Sub-Investigator: Erdinç Sarıdoğan, Assistant professor         
Sub-Investigator: Görkem Tuncay, Associate professor         
Sub-Investigator: Abdullah Karaer, Professor         
Sponsors and Collaborators
Inonu University
More Information
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Responsible Party: Senem Arda Düz, Assistant professor, Inonu University
ClinicalTrials.gov Identifier: NCT04831151    
Other Study ID Numbers: 2021/28
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Senem Arda Düz, Inonu University:
hirsutism
combined oral contraceptives
amenorrhea
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cyproterone acetate, ethinyl estradiol drug combination
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists