Status:
RECRUITING
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hypogonadism
Malignant Urinary System Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes...
Detailed Description
PRIMARY OBJECTIVE: I. To examine the safety and feasibility of perioperative testosterone replacement (TR) therapy in hypogonadal male patients undergoing major operations. OUTLINE: Patients are ass...
Eligibility Criteria
Inclusion
- Patients already scheduled for major surgery requiring an overnight hospital stay
- Patients must be able to give informed consent
- Patients must be willing to do study's preoperative and post-operative assessment tools
Exclusion
- Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
- Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
- Patients with history of/undergoing orchiectomy
- Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
- Patients who use anabolic steroids
- Patients with history of solitary or undescended testis
- Patients with history of pituitary disorders
- Patients with history of thromboembolic events in last year
- Patients with hematocrit \> 55%
- Patients with uncontrolled congestive heart failure
- Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04731376
Start Date
January 25 2021
End Date
December 31 2026
Last Update
December 27 2024
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322