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Clinical Trial 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.


Clinical Trial 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 assigned to 1 of 2 arms. ARM I: Patients with low testosterone levels receive testosterone cypionate intramuscularly (IM) once a week (QW) for 3 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients with normal testosterone levels receive standard peri-operative care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04731376
Study type Interventional
Source Emory University
Contact Kenneth Ogan, MD
Phone 404-778-3038
Email kogan@emory.edu
Status Recruiting
Phase Phase 1
Start date January 25, 2021
Completion date October 30, 2025

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