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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00382057
Eligibility Criteria:
Inclusion Criteria:
1. Age 50-75 yr
2. Diagnosis of the metabolic syndrome defined by the American Heart Association/National Heart, Lung, and Blood Institute guidelines as the presence of three or more of the following:
* Waist circumference \> 102 cm
* Serum triglycerides \> 150 mg/dL
* HDL cholesterol \< 40 mg/dL
* Blood pressure \> 130 mm Hg systolic or 85 mm Hg diastolic, or treatment with anti-hypertensives
* Fasting serum glucose \> 100 mg/dL
3. Plasma total testosterone level less than 300 ng/dL (1 SD below the mean for young healthy men)
4. Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)
5. Normal TSH, prolactin and prostate specific antigen (PSA) levels (\<2.5 ng/mL)
Exclusion Criteria:
1. New diagnosis of type 2 diabetes as defined by the ADA criteria: fasting glucose greater than 126 mg/dL or random blood glucose greater than 200 mg/dL on two occasions, or on oral hypoglycemic agents
2. History of testicular disorders (i.e. cryptorchidism)
3. History of bleeding disorders (i.e. thrombocytopenia) or baseline hemoglobin levels less than 12g/dL
4. History of prostate cancer
5. History of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence)
6. Symptoms of urinary outflow obstruction (i.e. benign prostatic hypertrophy)
7. Illicit drug use or heavy alcohol use (\>4 drinks/day)
8. Allergic disorders
9. Current medications (must exclude individuals taking the following medications: Testosterone, Cimetidine, Spironolactone, Ketoconazole, Finasteride, DHEA, Androstenedione, Oral steroids, GnRH analogs)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT00382057
Study Brief:
Protocol Section:
NCT00382057