The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yasmin
Diane-35
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring hirsutism, combined oral contraceptives, amenorrhea
Eligibility 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
Sites / Locations
- Inonu UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Drospirenone group: 0,03 mg ethinylestradiol + 3 mg drospirenone
cyproterone acetate group: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate
Arm Description
generic name:yasmin dosage form:oral dosage: 0,03 mg ethinylestradiol + 3 mg drospirenone frequency: once a day duration: 3 months
generic name:diane 35 dosage form:oral dosage: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate frequency: once a day duration: 3 months
Outcomes
Primary Outcome Measures
Metabolomics
measured by H1 nuclear magnetic resonance spectroscopy
Secondary Outcome Measures
hirsutism score
Measured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome.
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.
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.
body mass index
weight and height will be combined to report BMI in kg/m^2. The lower index means better results.
clinical findings
Rising the number of participants with menstrual periods shorter than 35 days means better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04831151
Brief Title
The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics
Official Title
The Effect of Two Combined Oral Contraceptives Containing Cyproterone Acetate or Drospirenone on Blood Metabolomics in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
hirsutism, combined oral contraceptives, amenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drospirenone group: 0,03 mg ethinylestradiol + 3 mg drospirenone
Arm Type
Active Comparator
Arm Description
generic name:yasmin dosage form:oral dosage: 0,03 mg ethinylestradiol + 3 mg drospirenone frequency: once a day duration: 3 months
Arm Title
cyproterone acetate group: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate
Arm Type
Active Comparator
Arm Description
generic name:diane 35 dosage form:oral dosage: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate frequency: once a day duration: 3 months
Intervention Type
Drug
Intervention Name(s)
Yasmin
Intervention Description
Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone
Intervention Type
Drug
Intervention Name(s)
Diane-35
Intervention Description
Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate
Primary Outcome Measure Information:
Title
Metabolomics
Description
measured by H1 nuclear magnetic resonance spectroscopy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
hirsutism score
Description
Measured by modified Ferriman Gallwey scoring system ranges between 0-36 points. Higher scores means worse outcome.
Time Frame
3 months
Title
fasting serum insulin levels
Description
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
Title
low density lipoprotein
Description
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
Title
body mass index
Description
weight and height will be combined to report BMI in kg/m^2. The lower index means better results.
Time Frame
3 months
Title
clinical findings
Description
Rising the number of participants with menstrual periods shorter than 35 days means better outcome.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Senem Arda Düz, Asisstant professor
Phone
+905332776401
Email
senem_arda@yahoo.com
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senem Arda Düz, Assistant Professor
Phone
+905332776401
Email
senem_arda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Erdinç Sarıdoğan, Assistant professor
First Name & Middle Initial & Last Name & Degree
Görkem Tuncay, Associate professor
First Name & Middle Initial & Last Name & Degree
Abdullah Karaer, Professor
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics
We'll reach out to this number within 24 hrs