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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00487734
Eligibility Criteria:
Inclusion Criteria: (subjects must meet both criteria)
* Metabolic syndrome (have 3 out of the following 4 criteria):
1. BP \> 130/85 or on antihypertensive therapy
2. Fasting glucose \> 100 mg/dl
3. Fasting TG \> 150 mg/dl or on a triglyceride lowering agent (fenofibrate, gemfibrozil, niacin in doses of \>= 500 mg/day, or fish oils in doses of \>=2000mg DHA+EPA)
4. Fasting HDL-C \< 40 mg/dl Note that the waist circumference will not be used as one of the criteria for the metabolic syndrome for this study because we are studying non-obese subjects.
* Total Testosterone less than 300 ng/dl
Exclusion Criteria:
* Women.
* Men less than 20 years of age.
* BMI \> or = to 30 kg/M2.
* Use of testosterone preparations within 1 year of the screening visit
* Use of hypoglycemic medications within the previous 3 months.
* Fasting blood glucose \> 126 mg/dl.
* The following men will be excluded because of the potential safety issues in the placebo treated group:
1. Creatinine greater than 1.4 mg/dl
2. Triglyceride levels greater than 500 mg/dl
3. HDL-C levels less than 20 mg/dl
4. Blood pressure greater than 160/90
* The following men will be excluded because of the potential side effects of testosterone therapy:
1. Men greater than 65 years of age
2. International prostate symptom score \>19
3. PSA greater than 2.5
4. History of benign prostatic hypertrophy
5. History of prostate cancer
6. Abnormal digital rectal exam
7. Hg greater than 16 mg/dl or Hct greater than 48%
8. peripheral edema
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT00487734
Study Brief:
Protocol Section:
NCT00487734