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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT05196568
Eligibility Criteria:
Inclusion Criteria:
* Female 18-40 years
* BMI 20-40
* Reproductive age women with PCOS diagnosis
* Irregular menstrual cycles
* Chronic oligo/anovulation defined as an intermenstrual interval of \>45 days
* \< 8 menstrual cycles/year
* evidence of either hyperandrogenemia (elevation of total or free testosterone above the normal range for women)
* clinical hyerandrogenism (hirsutism and or acne)
* 3 years from menarche
* Agree to avoidance of pregnancy and to use barrier contraception for duration of study
Exclusion Criteria:
* • Clinically ascertained presence of type I and type II Diabetes
* Pregnancy and/or nursing
* Medication exclusion
* Use of medications and/or supplements that influence either ovarian function or insulin sensitivity, within 2 months: including oral contraceptive pills, hormonal implants, anti-androgens, antipsychotics or antihypertensives metformin, glucocorticoids, and/or health food remedies other than multi-vitamins and calcium;
* Subjects who are on oral contraception, metformin, or nutritional supplements must agree to discontinue these drugs and undergo an 8 week washout period before the tests are performed
* Other drugs that cannot be suspended during the FMD phase
* Alcohol usage more than 7 drinks/week
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05196568
Study Brief:
Protocol Section:
NCT05196568