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NCT04731376 | RECRUITING | Hypogonadism

Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
Sponsor:

Emory University

Information provided by (Responsible Party):

Kenneth Ogan

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 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.

Condition or disease

Hypogonadism

Malignant Urinary System Neoplasm

Urinary System Disorder

Urinary System Neoplasm

Intervention/treatment

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Testosterone Cypionate

Phase

PHASE1

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 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 Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
Actual Study Start Date : 2021-01-25
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

Location Details

NCT04731376

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Georgia

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322