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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT00866450
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects
* Age between 50 and 72 years
* At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).
Exclusion Criteria:
* Personal history of cancer other than non-melanoma skin cancer within the past 10 years
* History of hereditary non-polyposis colon cancer
* Intestinal malabsorption, inflammatory bowel disease
* Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
* Any excess bleeding or coagulation disorders
* Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, \< 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function or inflammation
* Total cholesterol greater than 240mg/dl, triglycerides \> 600mg, LDL-C \> 175
* Subjects with a history of coronary artery disease
* HIV positive subjects
* Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subject is euthyroid)
* Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
72 Years
Study:
NCT00866450
Study Brief:
Protocol Section:
NCT00866450