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Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
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 such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. Studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. Testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. Information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.
Eligibility Criteria
Inclusion Criteria
- 1Patients already scheduled for major surgery requiring an overnight hospital stay
- 2Patients must be able to give informed consent
- 3Patients must be willing to do study's preoperative and post-operative assessment tools
Exclusion Criteria
- 1Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
- 2Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
- 3Patients with history of/undergoing orchiectomy
- 4Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
- 5Patients who use anabolic steroids
- 6Patients with history of solitary or undescended testis
- 7Patients with history of pituitary disorders
- 8Patients with history of thromboembolic events in last year
- 9Patients with hematocrit \> 55%
- 10Patients with uncontrolled congestive heart failure
- 11Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners
Locations
1 site participating in this study
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Kenneth Ogan, MD