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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00223860
Eligibility Criteria:
Inclusion Criteria:
1. SCI with serum total testosterone 3.0 ng/ml (SCI eugonadal, n=25),
2. SCI with serum total testosterone \<3.0 ng/ml (SCI hypogonadal, n=25),
3. able-bodied controls with serum total testosterone 3.0 ng/ml (control eugonadal, n=25), and
4. able-bodied controls with serum total testosterone \<3.0 ng/ml (control hypogonadal, n=25). All SCI and control subjects will be screened for serum gonadotropin levels within the normal range as an inclusion criterion.
Exclusion Criteria:
1. acute illness,
2. active thyroid disease,
3. pyschotropic medications,
4. anti-hypertensive medications (centrally acting, i.e., guanethidine, reserpine, methyldopa, b-adrenergic blockers, clonidine, etc.),
5. H2-blockers,
6. digoxin,
7. alcoholism,
8. anti-convulsant medications (dilantin or barbiturates)
9. diuretics (thiazides or spironolactone),
10. chemotherapeutic agents,
11. antibiotics,
12. opiates,
13. hormones (other than replacement doses),
14. history of pituitary or testicular surgery. Abstinence from alcoholic beverages will be required for 48 hours prior to study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00223860
Study Brief:
Protocol Section:
NCT00223860