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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01019356
Eligibility Criteria:
Inclusion Criteria:
PCOS :
* Biochemical hyperandrogenism (free testosterone ≥ 50 pmol/l)
* Oligomenorhea (≤ 8 menstrual cycle per year)
Health volunteers :
* Normal menstrual cycle
* Normal levels of free and total testosterone
* No family history with PCOS
Exclusion Criteria:
* Diabetes or glucose intolerance
* Current or past use within 3 months of oral contraceptives
* Current or past use within 3 months of medications known to affect insulin sensitivity (metformin, PPARy agonists, b-blockers, thiazides, calcium channel blockers, glucocorticoids, etc.)
* Pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious or neoplastic disease (other than non-melanoma skin cancer)
* Documented or suspected recent (within one year) history of drug abuse or alcoholism
* Use of any investigational drug within three months prior to study onset
Healthy volunteers :
* History of gestational diabetes
* Positive family history for first-degree relative with diabetes
* Disorders linked to insulin resistance (hypertension, dyslipidemia or acanthosis nigricans)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01019356
Study Brief:
Protocol Section:
NCT01019356