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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT01008904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Meets 1 of the following criteria:
* History of breast cancer (currently without malignant disease)
* No history of breast cancer but wishes to avoid estrogen due to a perceived increased risk of breast cancer
* Must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week and of sufficient severity to make the patient desire therapeutic intervention) for ≥ 1 month before study entry
* Has undergone treatment for cancer (patients other than breast cancer survivors are eligible)
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine clearance ≥ 30 mL/min
* No hypersensitivity to magnesium oxide
* No medical or other condition(s) that, in the opinion of the investigator/sub-investigator, may compromise the objectives of the study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, progestational agents, or gabapentin
* More than 28 days since prior and no other concurrent investigational drugs
* Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient has been on a constant dose for \> 4 weeks AND is not expected to stop the medication during the study period
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01008904
Study Brief:
Protocol Section:
NCT01008904