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

NCT04731376 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Hypogonadism
  • Malignant Urinary System Neoplasm
  • Urinary System Disorder
  • Urinary System Neoplasm

Interventions

OTHER

Best Practice

Receive standard peri-operative care

PROCEDURE

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively

DRUG

Testosterone Cypionate

Given IM

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Kenneth Ogan, MD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2024-11-26
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04731376 on ClinicalTrials.gov