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NCT04731376 · ClinicalTrials.gov registry record · Phase 1
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
A Phase 1 study of Hypogonadism and Malignant Urinary System Neoplasm, sponsored by Emory University.
- Active
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT04731376: Active Phase 1 study of Hypogonadism and Malignant Urinary System Neoplasm, sponsored by Emory University.
NCT04731376 is a Phase 1 study of Hypogonadism and Malignant Urinary System Neoplasm that is active but no longer recruiting, run by Emory University. The registered enrollment target is 56 participants, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04731376, a Phase 1 study of Hypogonadism and Malignant Urinary System Neoplasm, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- OTHER Best Practice
- DRUG Testosterone Cypionate
- PROCEDURE Quality-of-Life Assessment
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04731376 still lists
NCT04731376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (53% lower).
The record links to 4 conditions, with Hypogonadism appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT04731376 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04731376 about?
NCT04731376 is a clinical study titled "Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone". 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 testos...
What is the current status of trial NCT04731376?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2021-01-25. Estimated completion is 2026-12-31.
What conditions does trial NCT04731376 study?
This clinical trial studies the following conditions: Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder, Urinary System Neoplasm.
What interventions are being tested in trial NCT04731376?
The interventions under investigation include: Questionnaire Administration (OTHER), Best Practice (OTHER), Testosterone Cypionate (DRUG), Quality-of-Life Assessment (PROCEDURE).
Who is sponsoring clinical trial NCT04731376?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04731376 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04731376's enrollment target sits among peer trials
56 12th of 21 higher than 10 of 21 other Hypogonadism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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