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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT00917735
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Healthy postmenopausal women aged 50-70 years
* "Heterogeneously dense" (51-75% glandular) or "extremely dense" (\>75%glandular) breasts
* Willing to avoid consumption of green tea for 1 year
Exclusion Criteria:
* Positive serological markers of hepatitis B or hepatitis C infections
* Elevated levels of liver enzymes
* Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors
* Current smoker of cigarettes or other tobacco products
* BMI \<19 or \>40 kg/m2
* Weight change \> 10 lbs during the previous year
* History of breast cancer or proliferative breast disease
* Regular consumption of \> 7 alcoholic drinks/wk
* Regular consumption of green tea (\>1 cup/wk)
* Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors
* Participation in any weight loss or weight gain studies
* Currently taking Methotrexate or Enbrel
* History of ovarian cancer
* Any form of cancer in the last 5 years
* Presence of implants
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT00917735
Study Brief:
Protocol Section:
NCT00917735