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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT00906308
Eligibility Criteria:
Inclusion Criteria (limited):
* Confirmed postmenopausal women aged 40-65
* Provide written informed consent
Exclusion Criteria (limited):
* History of malignancy, with the exception of certain types of skin cancer or cervical cancer
* Known carrier of BRCA1 or BRCA2
* Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
* Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
* Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
* History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
* Active liver disease or gall bladder disease
* History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
* Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
* Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
* Chronic use of morphine or other opiates
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT00906308
Study Brief:
Protocol Section:
NCT00906308