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NCT01201863 · ClinicalTrials.gov registry record · Phase 4
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
A Phase 4 study, sponsored by Craig Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT01201863: Completed Phase 4 study, sponsored by Craig Hospital.
NCT01201863 is a Phase 4 study that has completed, run by Craig Hospital. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01201863, a Phase 4 study, has completed, sponsored by Craig Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation; (2) Document the natural history of neuroendocrine dysfunction and recovery in men during inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel assessment of neurological function for use in the TBI population; and 2 long-term objectives: (1) Utilize study findings to design a multicenter trial to further assess the impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management with new information about neuroendocrine dysfunction after TBI and hormone treatments to improve outcomes.
Primary Outcome
The FIM is the most widely accepted functional assessment measure in use in the rehabilitation community in the US. It is an 18-item ordinal clinician rating scale that is useful for assessment of functional skills progress during inpatient rehabilitation. It measures levels of independent/dependent performance of 13 motor functions and 5 cognitive functions. By adding the points for each item, the possible total score ranges from 18 to 126, with higher numbers indicating better performance. A r
Interventions
- DRUG Androgel (Testosterone Gel)
- OTHER Placebo gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT01201863 record still lists
NCT01201863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Androgel (Testosterone Gel) is the first listed.
NCT01201863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01201863 about?
NCT01201863 is a clinical study titled "Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy". The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation; (2) Document the natural...
What is the current status of trial NCT01201863?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2010-09. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01201863?
The interventions under investigation include: Androgel (Testosterone Gel) (DRUG), Placebo gel (OTHER).
Who is sponsoring clinical trial NCT01201863?
This trial is sponsored by Craig Hospital, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01201863's enrollment target sits among peer trials
46 1348th of 2000 higher than 647 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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