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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT01664650
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal satus
* The presence of three or more of the five following criteria:
1. waist circumference ≥88 cm;
2. Triglycerides ≥150 mg/dl or on drug treatment for elevated triglycerides;
3. high-density-lipoprotein (HDL) cholesterol \<50 mg/dl or on drug treatment for reduced HDL-C;
4. Fasting glucose ≥100 mg/dl or on drug treatment for elevated glucose;
5. Blood pressure ≥130/85 mmHg or on antihypertensive drug treatment in a subject with a history of hypertension.
Exclusion Criteria:
* clinical or laboratory evidence of confounding systemic diseases (e.g., chronic renal or hepatic failure, chronic inflammatory diseases)
* cardiovascular disease (CVD) defined as documented myocardial infarction, ischaemic heart disease, coronary heart bypass, coronary angioplasty, cerebral thromboembolism, and peripheral amputations, or by Minnesota codes 1°1-3, 4°1-4, 5°1-3 at a standard ECG performed in the 12 months preceding the study;
* coagulopathy;
* use of oral or transdermal estrogen, progestin, androgens, selective estrogen receptor modulators, or other steroids;
* treatment in the preceding six months with polyunsaturated n-3 fatty acids supplements, non steroidal anti-inflammatory drugs (NSAIDs) or steroids, that would interfere with evaluation of the study medication;
* smoking habit of more than 2 cigarettes daily.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
49 Years
Maximum Age:
67 Years
Study:
NCT01664650
Study Brief:
Protocol Section:
NCT01664650