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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00743327
Eligibility Criteria:
Inclusion Criteria:
* Men 18 years of age or older with prostate cancer
* Planning to undergo long-term (at least 12 months) ADT
* No known history of diabetes
* No history of ADT
Exclusion Criteria:
* History of ADT or any prior diagnosis of hypogonadism
* Fasting glucose or oral glucose tolerance test results in the diabetic range
* Heart failure (NY classification III or IV)
* Testosterone level less than 250 ng/dl on screening
* History of heart attack or open-heart surgery within the past 6 months
* Use of steroids within the past 3 months, including prednisone, cortisone injections, inhaled steroids (topical steroids are acceptable)
* Use of anabolic steroids (testosterone, DHEA, DHEAS) or any growth promoters (growth hormone itself or analogs of growth hormone) in the past 12 months
* Liver function tests more than 3 times upper normal limits
* Undergoing intermittent ADT
* Uncontrolled thyroid disease (hyper- or hypo-thyroidism)
* Anemia, defined as hematocrit less than 38%
* Not physically capable of completing the tests
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00743327
Study Brief:
Protocol Section:
NCT00743327