Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study

Who is this study for? Patients with Hypogonadism, Urinary System Disorder
What treatments are being studied? Quality-of-Life Assessment+Questionnaire Administration+Testosterone Cypionate
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Procedure
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Contact Information
Primary
Kenneth Ogan, MD
kogan@emory.edu
404-778-3038
Time Frame
Start Date: 2021-01-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Arm I (testosterone cypionate)
Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.
Active_comparator: Arm II (best practice)
Patients with normal testosterone levels receive standard peri-operative care.
Related Therapeutic Areas
Sponsors
Leads: Emory University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov