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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT00099008
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Healthy participants
* Papanicolaou test (pap smear) normal within the past 13 months
* Mammogram normal within the past 13 months
* No history of breast cancer
* Not at high-risk (5-year risk \< 1.9%) for breast cancer according to NCI's Breast Cancer Risk Assessment Tool
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 45 to 70
Sex
* Female
Menopausal status
* Postmenopausal
* Last spontaneous menstrual bleeding \> 12 months ago
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2.0 mg/dL
* ALT and AST \< 2 times normal
* No significant abnormality of the liver by physical exam
Renal
* Creatinine \< 2.0 mg/dL
Cardiovascular
* No significant cardiac disease
* No New York Heart Association class III or IV heart disease
* No significant abnormality of the heart by physical exam
Pulmonary
* No significant abnormality of the lung by physical exam
Other
* Body mass index \< 35
* Follicle-stimulating hormone \> 27 mIU/mL
* Thyroid or endocrine function test normal
* Alcohol intake ≤ 2 drinks/day or ≤14 drinks/week
* Not pregnant
* No intermediate equol values (≥10 ug/L to ≤ 20 ug/L) on soy challenge
* No history of seizures
* No significant abnormality of the spleen or other abdominal organs by physical exam
* No neurologic abnormality by physical exam
* No significant metabolic abnormality on the biochemical screen
* No history of substance abuse or addiction
* No tobacco use
* No diets containing \> 20 mg of genistein/day or \> 40 mg isoflavone/day
* No known intolerance to soy
* No other serious medical illness
* No active malignancy or malignancy initially diagnosed within the past 2 years except curatively treated nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 2 years since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* More than 3 months since prior hormonal or estrogen therapy
* More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators
* More than 1 month since prior supplements containing phytoestrogens or that have estrogenic side effects (soy isoflavones or PC-SPECS)
* No concurrent thyroid medication
* Other concurrent endocrine medication allowed provided medication was initiated ≥ 3 months before study entry AND participant has been on a stable regimen for the past 3 months
Radiotherapy
* Not specified
Surgery
* No prior hysterectomy or oophorectomy
Other
* More than 3 months since prior antibiotics
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT00099008
Study Brief:
Protocol Section:
NCT00099008