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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT00470561
Eligibility Criteria:
INCLUSION CRITERIA:
* Moderate or high density breast tissue on mammogram within the past 4 months
* Breast Imaging-Reporting and Data System (BIRAD) class 2-4 or digitized mammogram with ≥ 25% density
* Healthy without serious comorbidities
* Female
* Postmenopausal
* More than 3 weeks since prior and no other concurrent use (2 or more times per week) of acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
EXCLUSION CRITERIA:
* history of breast cancer, including ductal carcinoma in situ or lobular carcinoma in situ
* history of illness for which NSAIDs are typically primary therapy (e.g., rheumatoid arthritis)
* Allergy to NSAIDs
* Anemia (hematocrit \< 35%), abnormal bleeding tests, or bleeding disorders
* Gastrointestinal (GI) ulcer or history of GI bleeding
* Adverse reactions to aspirin acid or other NSAIDs
* Renal disease
* Asthma
* Current or chronic liver disease
* History of hemorrhagic stroke or transient ischemic attack
* History of coronary artery disease, including any of the following:
* Myocardial infarction (MI)
* Angina
* Coronary artery disease documented on cardiac catheterization, exercise thallium, or exercise echocardiogram
* Strong family history of coronary artery disease (i.e., mother with MI before 55 years of age, father with MI before 45 years of age)
* Documented carotid artery disease
* Diabetes
* Uncontrolled hypertension
* No planned extensive weight loss in the next 6 months (≥ 10 pounds)
* More than 2 alcoholic drinks daily
* Mental illness or alcohol or drug abuse
* Prior angioplasty or coronary artery bypass grafting
* Prior breast implantation or reduction surgery
* Less than 6 months since prior hormones for menopause (including pills, patches, vaginal route), tamoxifen citrate, raloxifene, other hormonal therapy, or herbal or soy preparations
* Concurrent anticoagulation medication
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT00470561
Study Brief:
Protocol Section:
NCT00470561