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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT01733459
Eligibility Criteria:
Inclusion Criteria:
* Female subjects in reproductive age (i.e. 18-40 years)
* Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the Rotterdam Criteria
* Subject with insulin resistance defined by: HOMA-IR of \> 2.00
Exclusion Criteria:
* Pregnant and lactating women
* Subjects known to have Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia
* Known to have current medical condition, which, is judged by the Investigator could jeopardize subject's health or interfere with the study evaluation, such as diabetes mellitus, uncontrolled hypertension, other cardiovascular diseases, acute or chronic infections, and any known malignancies
* Impaired renal function (serum creatinine level \> 1.5 ULN)
* Impaired liver function (serum ALT level ≥ 2.5 ULN)
* Medically-assisted weight loss with medications or surgical procedures
* Currently having laparoscopic ovarian diathermy (LOD)
* Currently under treatment with in vitro fertilization (IVF) techniques
* Have been regularly taking any medications which affect insulin sensitivity as well as reproductive function (i.e. ovulation, menstrual cycle), within ≤ 3 months prior to screening
* Participating in other clinical trial within 30 days prior to screening
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01733459
Study Brief:
Protocol Section:
NCT01733459