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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01862835
Eligibility Criteria:
Inclusion:
* 60 healthy men (ages 60 to 80 y);
* BMI 18-30 kg/m2
* Community dwelling; and voluntarily consenting
Exclusion:
* Recent use of psychotropic or neuroactive drugs (within five biological half-live);
* Obesity (outside weight range above);
* Laboratory test results not deemed physician acceptable, cholesterol \>250, triglycerides \> 300, BUN \>30 or creatinine \> 1.5 mg/dL, liver functions tests twice upper limit of normal, electrolyte abnormality, anemia; hemoglobin \<12.0 gm/dL
* Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
* Acute or chronic organ-system disease;
* Endocrinopathy, other than primary thyroidal failure receiving replacement; untreated osteoporosis
* Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
* Acute weight change (loss or gain of \> 2 kg in 6 weeks);
* Allergy to peanut oil (used in some injectable Te preparations)
* Unwillingness to provide written informed consent.
* PSA \> 4.0 ng/mL
* History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy.
* History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence.
* History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis.
* History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
* Gynecomastia \> 2 cm, untreated
* Untreated gallbladder disease
* History of smoking greater than one ppd.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT01862835
Study Brief:
Protocol Section:
NCT01862835