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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00070733
Eligibility Criteria:
Inclusion Criteria
* General good health and capable of undergoing strength testing
* Normal testosterone (300-1100 ng/dL), LH, and FSH levels
Exclusion Criteria
* Currently participating in competitive sports
* Mental state that would preclude complete understanding of the protocol and compliance
* Disorder known to cause or be associated with hypogonadism (e.g., pituitary tumors, hyperprolactinemia, HIV infection, or Klinefelter's Syndrome)
* More than 20% over ideal body weight
* Disabilities that would prevent participation in strength testing (e.g., amputation of limbs, blindness, severe arthritis, angina, or neurologic disorders such as Parkinson's disease, stroke, or myopathy)
* Uncontrolled hypertension, diabetes, congestive heart failure, or chronic obstructive lung disease
* Alcohol or drug dependence in the 6 months prior to study entry
* Disorders that might be exacerbated by androgen treatment (e.g., benign prostatic hyperplasia or prostate cancer, erythrocytosis \[hematocrit \> 51% at baseline\], or sleep apnea assessed by Berlin's questionnaire)
* Serum PSA levels \> 4 microg/L
* AST, ALT, or alkaline phosphatase elevation greater than three times the upper limit of normal
* Creatinine greater than 2 mg/dL
* Medications that might affect muscle or bone metabolism (e.g., glucocorticoid, rhGH, androgenic steroids, oral androgen precursors such as androstenedione or DHEA) or androgen metabolism, action, or clearance (e.g., dilantin, phenobarbitol, aldactone, flutamide, finasteride)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT00070733
Study Brief:
Protocol Section:
NCT00070733