HypogonadismPhase 1NCT04731376
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
A Phase 1 study testing Best Practice, Quality-of-Life Assessment and Questionnaire Administration in people with Hypogonadism and Malignant Urinary System Neoplasm, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder
- What is being tested?
- Best Practice, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder, Urinary System Neoplasm
- Being tested
- Best Practice, Quality-of-Life Assessment, Questionnaire Administration, Testosterone Cypionate
- Medical subject headings
- Hypogonadism, Urologic Neoplasms, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard peri-operative care
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively
Testosterone CypionateDrug
Also called depAndro, Depo-Testosterone, Depotest, Depovirin
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Arm I (testosterone cypionate) | Experimental | Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months. Receives: Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate |
| Arm II (best practice) | Active comparator | Patients with normal testosterone levels receive standard peri-operative care. Receives: Other: Best Practice; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life before and after surgery
The Patient Reported Outcomes Measurement Information System (PROMIS Global Health-10) is a 10 question survey that uses questions concerning physical function, overall quality of life, physical health, mood, ability to participate in social roles and activities, pain and fatigue to arrive at a score between 10 and 50. Patient's score are the outcome we will measure.
Measured: Baseline to 3 months
Change in frailty phenotype before and after surgery
The Fried Frailty Criteria uses a comorbidity scale, measures of activity, physical tests of strength and speed, nutritional status and anatomic features to produce a score from 0-5. These numbers correspond with the following frailty categorizations: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5). This score represents one outcome measure.
Measured: Baseline, post operative refers to the period after the procedure until final follow up and study completion. Will occur an average of 90 days after the procedure.
Major complications
Major complication considered Clavien-Dindo IIIb and above.
Measured: Within 90 days of surgery
Minor complications
Minor complication considered Clavien-Dindo IIIb and below.
Measured: Within 90 days of surgery
Rate of intensive care unit (ICU) admission
Admissions to the ICU between post-op day 1 to 90 days post surgery
Measured: Up to 3 months post-surgery
Hospital length of stay
Number of days stayed in the hospital after surgery
Measured: Up to 3 months post-operative
Discharge disposition
Determined by if patient is discharged to home, to home with services, or to facility.
Measured: Discharge from hospital
Unplanned readmissions
Readmissions to hospital after discharge within 90 days
Measured: Within 90 days of surgery
Mortality rate
Rate of patient deaths after surgery
Measured: Within 90 days of surgery
Testosterone level
Levels of Testosterone determined by laboratory blood draw
Measured: Up to 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start25 Jan 2021
- Primary completion26 Nov 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kenneth Ogan, Emory University
- Investigators
- Kenneth Ogan, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731376
- Sponsor's protocol ID
- STUDY00001062
- Other IDs
- NCI-2020-06998, EU5097-20, P30CA138292
- Status last verified
- May 2026
- First submitted
- 13 Jan 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT04731376
- Acronym / sponsor ID
- STUDY00001062
- Conditions
- Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder, Urinary System Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (testosterone cypionate) | Experimental | Procedure: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone CypionatePatients with low testosterone levels receive testosterone cypionate IM QW for 3 months. |
| Arm II (best practice) | Active comparator | Other: Best Practice, Procedure: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients with normal testosterone levels receive standard peri-operative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard peri-operative care | Other | Arm II (best practice) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Arm I (testosterone cypionate), Arm II (best practice) |
| Questionnaire AdministrationAncillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively | Other | Arm I (testosterone cypionate), Arm II (best practice) |
| Testosterone CypionateAlso: depAndro, Depo-Testosterone, Depotest, DepovirinGiven IM | Drug | Arm I (testosterone cypionate) |
Primary outcome
Changes in quality of life before and after surgery
Time frame: Baseline to 3 months
The Patient Reported Outcomes Measurement Information System (PROMIS Global Health-10) is a 10 question survey that uses questions concerning physical function, overall quality of life, physical health, mood, ability to participate in social roles and activities, pain and fatigue to arrive at a score between 10 and 50. Patient's score are the outcome we will measure.
Change in frailty phenotype before and after surgery
Time frame: Baseline, post operative refers to the period after the procedure until final follow up and study completion. Will occur an average of 90 days after the procedure.
The Fried Frailty Criteria uses a comorbidity scale, measures of activity, physical tests of strength and speed, nutritional status and anatomic features to produce a score from 0-5. These numbers correspond with the following frailty categorizations: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5). This score represents one outcome measure.
Major complications
Time frame: Within 90 days of surgery
Major complication considered Clavien-Dindo IIIb and above.
Minor complications
Time frame: Within 90 days of surgery
Minor complication considered Clavien-Dindo IIIb and below.
Rate of intensive care unit (ICU) admission
Time frame: Up to 3 months post-surgery
Admissions to the ICU between post-op day 1 to 90 days post surgery
Hospital length of stay
Time frame: Up to 3 months post-operative
Number of days stayed in the hospital after surgery
Discharge disposition
Time frame: Discharge from hospital
Determined by if patient is discharged to home, to home with services, or to facility.
Unplanned readmissions
Time frame: Within 90 days of surgery
Readmissions to hospital after discharge within 90 days
Mortality rate
Time frame: Within 90 days of surgery
Rate of patient deaths after surgery
Testosterone level
Time frame: Up to 3 months post-operative
Levels of Testosterone determined by laboratory blood draw
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Ogan, MD principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Best Practice, Quality-of-Life Assessment and Questionnaire Administration in people with Hypogonadism and Malignant Urinary System Neoplasm, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life before and after surgery (time frame: Baseline to 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.