Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
NCT ID: NCT04731376
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2021-01-25
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I (testosterone cypionate)
Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.
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
Arm II (best practice)
Patients with normal testosterone levels receive standard peri-operative care.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Kenneth Ogan
Principal Investigator
Principal Investigators
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Kenneth Ogan, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Mersiha Torlak
Role: primary
Other Identifiers
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NCI-2020-06998
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU5097-20
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00001062
Identifier Type: -
Identifier Source: org_study_id