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 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT02099461
Eligibility Criteria:
INCLUSION CRITERIA:
* Willing to use, in combination with her partner, 2 non-hormonal methods of effective contraception or practice sexual abstinence. Subjects who are surgically sterile (eg, history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use contraceptive measures
* Laboratory tests are within clinically acceptable range
* Clinically acceptable physical exam and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.
EXCLUSION CRITERIA:
* Female subject with a prior history of breast cancer; breast implant in the breast to be biopsied; Known history of fibrocystic breast disease
* Subject is unable or unwilling to provide breast biopsy tissue from the upper outer quadrant of her breast
* Pregnant or plans to become pregnant while exposed to investigational product
* Lactating/breastfeeding or plans to breastfeed while exposed to investigational product
* Recent use of any non-approved medications or devices
* Uncontrolled thyroid disorder
* Significant dental/oral disease
* Planned invasive dental procedures
* Positive urine screen for alcohol and/or drugs
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02099461
Study Brief:
Protocol Section:
NCT02099461