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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT01766557
Eligibility Criteria:
Inclusion Criteria:
* women
* 18 to 45 years old
* having polycystic ovarian syndrome
* overweight (BMI\>27)
* insulin resistance based on fasting insulin levels in the upper 95th percentile (\>90pmol/L)
* non-diabetic
Exclusion Criteria:
* diabetes
* hysterectomy
* abnormal endometrial biopsy if abnormal bleeding in the last 6 months
* clinical evidence of Cushing's syndrome
* congenital adrenal hyperplasia (17-OH progesterone\>10nmol/l)
* excessive androgens suspicious of a tumour
* prolactins levels \>50μg/l
* previous breast, uterus, ovary or liver neoplasia
* use of medication known to affect glucose and lipid metabolisms (e.g. steroid hormones, oral contraceptives, ß-blockers, glitazones, statins, insulin)
* depo-medroxyprogesterone acetate injection in the last year
* important weight loss or weight gain within the last 6 months
* chronic, metabolic (except well controlled chronic hypothyroidism) or acute disease or major surgery within the last 3 months
* dietary incompatibility with calcium supplementation and/or fish consumption (allergy, intolerance, dislike)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01766557
Study Brief:
Protocol Section:
NCT01766557