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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01396369
Eligibility Criteria:
Inclusion Criteria:
* Must be 18 to 40 year old female with:
* Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score \>8, and/or hyperandrogenemia defined as total testosterone \>80ng/dl or bioavailable testosterone \>8.4 ng/dl.
* Mentally competent.
Exclusion Criteria:
* Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
* Long-term or chronic use of oral antibiotics.
* Hysterectomy.
* FSH \>15.
* Pregnancy/lactation.
* Consumption of flaxseed within the last month.
* Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
* Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01396369
Study Brief:
Protocol Section:
NCT01396369