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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00398034
Eligibility Criteria:
Inclusion Criteria:
* Adult male patients (above 18 years old and below 60 years old)
* Receiving greater than 20 IV morphine equivalents/day with \<20% change in dosage in the last month.
* AM total testosterone \<300 ng/dL
* Report "worst pain during the past week" grater than 4 on an 11-point numeric scale.
Exclusion Criteria:
* Females
* Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression)
* Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
* History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater than 4.0 ng/m
* History of polycythemia
* Renal or hepatic dysfunction
* Hematocrit \>55%
* Known history of hypersensitivity to transdermal testosterone gel.
* Abnormalities during digital rectal exam.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00398034
Study Brief:
Protocol Section:
NCT00398034