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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 is a Phase 4 study that has completed, run by Craig Hospital. The registered enrollment target is 46 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01201863
The ClinicalTrials.gov registry entry for NCT01201863 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Craig Hospital, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Androgel (Testosterone Gel) is the first listed.
NCT01201863 reports 0 study locations.
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.
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