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Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
Sponsor: Emory University
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 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.
Official title: Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2021-01-25
Completion Date
2026-12-31
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Best Practice
Receive standard peri-operative care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively
Testosterone Cypionate
Given IM
Locations (1)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States