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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT00365794
Eligibility Criteria:
Inclusion Criteria:
* Entry Criteria:
* Men \> 60 years of age
* Total testosterone \< 300 ng/dL
* Waist circumference \>102 cm
* Fasting insulin level \> 18 U/L
Exclusion Criteria:
* PSA \> 4.1, symptoms of obstructive uropathy (AUA score \> 14), unexplained prostate nodule or gland firmness
* Hematocrit \> 50%
* Malignancy other than cutaneous cancers
* Sleep apnea requiring CPAP
* History of myocardial infarction, angina or stroke within the previous 6 months
* Clinical diagnosis of diabetes or FPG \> 126 mg/dL
* Hypothyroidism not controlled to euthyroid levels with medication for at least 3 months
* LDL-C \>160 mg/dL
* Transaminases \> 1.5X ULN
* Systemic anticoagulation with warfarin
* Active progressive resistance training
* Dieting for weight loss
* Active inflammatory condition (e.g. rheumatoid arthritis)
* Use of any anabolic agent (e.g. growth hormone, testosterone precursor, anabolic steroid)or cytokine therapy in the proceeding 12 months
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT00365794
Study Brief:
Protocol Section:
NCT00365794