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 @ 11:06 PM
Ignite Modification Date:
2025-12-24 @ 11:06 PM
NCT ID:
NCT04798469
Eligibility Criteria:
Inclusion Criteria:
* Men, age 18 years and older.
* Chronic non-cancer spinal pain.
* Use of opioid analgesics for at least 6 months.
* Serum total testosterone (measured by mass spectrometry) \<348 ng/dL and/or free testosterone \<70 pg/mL.
* Ability and willingness to provide informed consent.
Exclusion Criteria:
* History of prostate cancer or breast cancer.
* Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
* Use of testosterone within the past 6 months.
* Baseline hematocrit \>48%.
* Prostate-specific antigen (PSA) level \>4 ng/mL in Caucasians or \>3 ng/mL in African-Americans.
* Presence of prostate nodule or induration on digital rectal examination.
* Uncontrolled congestive heart failure.
* Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
* Serum creatinine \>2.5 mg/dL.
* Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
* Diagnosis of bipolar disorder or schizophrenia.
* Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04798469
Study Brief:
Protocol Section:
NCT04798469