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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT04593459
Eligibility Criteria:
Inclusion Criteria:
* Polycystic Ovary Syndrome diagnosed based on at least two out of three rotterdam criteria: hyperandrogenism, polycystic ovarian morphology, oligo-/anovulation
* signed informed consent
Exclusion Criteria:
* Missing or withdrawn consent
* Hyperandrogenism of a cause other than PCOS (Cushing´s syndrome, hyperprolactinemia, adrenal tumours, congenital adrenal hyperplasia, rare genetic disorders)
* Pregnancy or nursing period (first 6 months after giving birth)
* Soy or other allergies with respect to study procedures
* Diabetes mellitus type 1
* Chronic inflammatory bowel disease, history of cancer in the gastrointestinal tract or acute gastrointestinal infection
* Any malignancies that required treatment within the last 3 years prior to study procedures
* Any other chronic disease requiring medical check-ups or hospital treatments at least once every three months (exception: diabetes mellitus type 2)
* Major surgery in the gastrointestinal tract (e.g. colectomy, gut segment excision with stoma surgery, Whipple´s surgery.) Surgical removal of the appendix and/or the gall bladder is NOT considered major surgery.
* Therapy with antidiabetic drugs (metformin, sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, Glucagon-like peptide 1 (GLP-1) analogs, sodium-glucose-cotransporter 2 (SGLT-2) inhibitors, insulin variants) within the last six months prior to study procedures
* Therapy with proton pump inhibitors within the last six months prior to study procedures
* Therapy with hormonal contraceptives or systemic (oral) intake of steroids within the last six months prior to study procedures
* Oral or intravenous therapy with antibiotics less than three months before the onset of study procedures
* Alcohol and/or drug abuse
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04593459
Study Brief:
Protocol Section:
NCT04593459