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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00080756
Eligibility Criteria:
Inclusion Criteria:
* Patients must generally be in good health with lab values and physical examination within normal limits
* Known high risk of breast cancer due to BRCA mutation or empiric risk \> 30% lifetime by the Claus model
* No evidence or history of pervious cancer, except non-melanoma skin cancer
* Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
* Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
* Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations
* Must be current non-smoker
Exclusion Criteria:
* GnRHA treatment within 12 months of study entry
* Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
* Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
* Pregnant or breast-feeding or have been so in the last six months
* Immeasurable breast density on mammogram
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
48 Years
Study:
NCT00080756
Study Brief:
Protocol Section:
NCT00080756