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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00774267
Eligibility Criteria:
Inclusion Criteria:
* Subjects who have completed all scheduled evaluations in protocol 3115A1-303-WW.
* Completed 24 months of treatment in protocol 3115A1-303.
* Had a mammogram at the baseline visit and at the month 24 visit in protocol 3115A1-303, and both are original films that are technically acceptable for reading.
* Was at least 80% compliant with test article administration during protocol 3115A1-303.
Exclusion Criteria:
* Had a mammogram at either baseline or month 24 during the 3115A1-303 study that was technically unsatisfactory.
* One or both mammograms were digitized when they were obtained during the 3115A1-303 study.
* Had more than one mammogram at either the baseline or month 24 visit of study 3115A1-303.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00774267
Study Brief:
Protocol Section:
NCT00774267