Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT06836128
Eligibility Criteria:
Inclusion Criteria:
1. Female aged 20 to 45 years old.
2. Confirmed diagnosis with PCOS according to the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.
3. Ability to give informed consent.
Exclusion Criteria:
1. Hypersensitivity to either metformin or NAC.
2. Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.
3. Hyperprolactinemia, defined as a prolactin level above laboratory reference range.
4. Diabetes mellitus.
5. Thyroid dysfunction, subjects with elevated or low TSH level.
6. Renal impairment where creatinine clearance (CrCl) less than 30 ml/min.
7. Severe hepatic impairment, defined as significant biochemical abnormalities, including hypoalbuminemia and abnormal serum concentration (2-3 times the upper limit of normal), of at least two of the following liver function markers: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT).
8. Active alcohol abuse.
9. History of lactic acidosis during metformin therapy.
10. Active peptic ulcer.
11. Congenital adrenal hyperplasia.
12. Cushing's syndrome.
13. Androgen secreting neoplasia.
14. Patients who were using spironolactone, other anti-androgens, or any form of hormone therapy for the treatment of hirsutism at least 3 months before enrollment in the study.
15. Decompensated heart failure.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT06836128
Study Brief:
Protocol Section:
NCT06836128