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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT00165204
Eligibility Criteria:
Inclusion Criteria:
* Good overall health
* Premenopausal at the time of enrollment if before their oophorectomy
* Will undergo or have undergone an oophorectomy
* Negative breast examination and negative breast imaging studies
Exclusion Criteria:
* History of breast cancer, ductal carcinoma in situ (DCIS) or other cancer except for carcinoma in situ of the cervix or basal cell carcinoma of the skin
* History of ovarian cancer, breast cancer (or DCIS) or other malignancy
* Low bone mass compared with age-adjusted controls
* Current or recent exposure (within 3 months) to medications that alter bone metabolism
* Estrogens, progesterones, androgens, tamoxifen or raloxifene within 3 months of randomization
* History of significant medical problems potentially related to estrogens
* History of Paget's disease of bone, ankylosing spondylitis, rheumatoid arthritis or other metabolic bone disease, vitamin D deficiency, hyperparathyroidism, or newly diagnosed hyperthyroidism
* Body mass index (BMI) \> 32
* High-density lipoprotein (HDL) cholesterol \< 40 mg/dl
* Women whose uterus was retained and who have a history of uterine abnormalities
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00165204
Study Brief:
Protocol Section:
NCT00165204