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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07399535
Eligibility Criteria:
Inclusion Criteria:
* Female subjects of reproductive age (18-40 years).
* Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria.
* Subjects with insulin resistance defined as HOMA-IR \> 2.00.
Exclusion Criteria:
* Pregnant or lactating women.
* Subjects with known Cushing's syndrome.
* Subjects with late-onset congenital adrenal hyperplasia.
* Subjects with androgen-secreting tumors.
* Subjects with uncontrolled thyroid disease.
* Subjects with hyperprolactinemia.
* Subjects with diabetes mellitus.
* Subjects with uncontrolled hypertension.
* Subjects with other cardiovascular diseases.
* Subjects with acute or chronic infections.
* Subjects with any known malignancy.
* Subjects with impaired renal function (serum creatinine \> 1.5 × ULN).
* Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07399535
Study Brief:
Protocol Section:
NCT07399535