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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT02803268
Eligibility Criteria:
Inclusion Criteria:
* Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal
* Subjects who have ≥7 Vasomotor Symptoms per day on average
* A body weight of ≥45 kg
Exclusion Criteria:
* Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product in the previous year, or any study within 12 weeks
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
* Clinically relevant abnormal medical history, physical findings or laboratory values
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02803268
Study Brief:
Protocol Section:
NCT02803268