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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT03981861
Eligibility Criteria:
Inclusion Criteria:
* Generally healthy
* Meeting Androgen Excess Society (AES) diagnostic criteria of PCOS: Menstrual Dysfunction or PCO ovaries on ultrasound AND clinical or biochemical hyperandrogenism
* Normal liver and kidney function
* No chronic illnesses except for stable, treated hypothyroidism
Exclusion Criteria:
* Use of metformin and/or spironolactone within the last 6 months
* Currently on either oral hormonal contraception or other forms of hormonal contraception such as Depo-Provera, NuvaRing
* Current or past pregnancy
* Currently sexually active
* Psychiatric disorder based on self/parental report
* Type 2 diabetes (blood glucose \> 200mg/dl on OGTT)
* Anemia (Hct \< 35)
* Impaired kidney function (Baseline creatinine \> 1.0 mg)
* Abnormal liver transaminases \> 2 x the upper limit of normal range
* Potassium elevated outside the reference range (in non-hemolyzed blood sample)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
21 Years
Study:
NCT03981861
Study Brief:
Protocol Section:
NCT03981861