Endocrine DysfunctionPhase 4NCT01201863
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
A Phase 4 study testing Androgel (Testosterone Gel) in people with Endocrine Dysfunction and Trauma, run by Craig Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 65 years, men only
- Conditions the study is for
- Endocrine Dysfunction, Trauma, Brain Injury
- What is being tested?
- Androgel (Testosterone Gel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of TBI as defined as "damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination;"82
- Moderate to severe TBI as indicated by a Glasgow Coma Scale (GCS) score of less than or equal to 12 at emergency department admission, or post traumatic amnesia (PTA) of greater than or equal to seven days post-injury, or radiographic evidence of intracranial injury;
- Continuously hospitalized from time of injury until admission for rehabilitation;
- Enrolled in study within 6 months of TBI;
- Receiving inpatient rehabilitation for TBI at Craig Hospital;
- Males between the ages of 16 to 65 (inclusive);
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- Approval by attending physician;
- Testosterone level below the assay normal range;
- Consent to study participation
Who cannot join
- History of any conditions that would prohibit testing contained in the NIH toolbox;
- Non-English or non-Spanish speaking (to the extent that would limit the ability to complete study measures);
- History of prior psychiatric illness requiring hospitalization;
- Prior testosterone therapy;
- History of or current or suspected hormonally dependent cancer , including carcinoma of the breast or prostate cancer;
- Known hypersensitivity to any T gel ingredients including alcohol and soy products;
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- Hematocrit (HCT) greater than 55% (normal range in Colorado is up to 52) or transaminase elevation >4x upper limit of the normal range.
- Abnormal finding on digital rectal examination such as nodule, asymmetry, or induration (Does not include enlarged prostate or abnormal rectal tone)
- PSA>4.0
- BMI <16 or >40kg/m2
- History of untreated prolactinoma
- History of severe heart failure or uncontrolled medical problem that would interfere with the participant's safety in the study as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This randomized, double blind, placebo-controlled pilot study assessed the hormonal status of men on admission to an inpatient TBI rehabilitation program. 498 consecutively admitted men for TBI rehabilitation were screened for participation in the study. 22 participants with low T who met all criteria were randomized into placebo (n=10), or physiologic T therapy (n=12). Of those with normal T who met all criteria, 24 were randomized into a follow up group. All participants were evaluated every two weeks for up to 12 weeks: hormone levels, FIM ratings and NIH Toolbox testing as able. There was participant drop out over time as participants were discharged from the hospital. The final analysis examined differences between the normal T, low T Treatment and low T placebo groups on hormone levels, FIM ratings and NIH Toolbox results at baseline and weeks 2, 4 and 6.
- Conditions
- Endocrine Dysfunction, Trauma, Brain Injury
- Being tested
- Androgel (Testosterone Gel), Placebo gel
- Keywords
- Testosterone, Traumatic Brain Injury, Hypogonadism, Endocrine Dysfunction, Low Testosterone in men with new Traumatic Brain Injury
- Medical subject headings
- Wounds and Injuries, Brain Injuries, Brain Injuries, Traumatic, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgel (Testosterone Gel)Drug
2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.
Placebo gelOther
2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.
| Study group | Role | What they receive |
|---|---|---|
| Low T Intervention - Androgel Treatment | Experimental | Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to the Androgel treatment group. They underwent hormonal assays, FIM ratings and NIH Toolbox testing at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. Receives: Drug: Androgel (Testosterone Gel) |
| Low T Intervention - Placebo Treatment | Placebo comparator | Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to the Placebo gel treatment group. They underwent hormonal assays, FIM ratings and NIH Toolbox testing at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. Receives: Other: Placebo gel |
| Normal T | No intervention | A subset of men with TBI meeting study criteria with normal T at screening were assessed at all data collection time points to provide a control group. Thirty-eight men obtained normal T levels at screening of which 24 were followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restricted Functional Independence Measure (FIM)
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 restricted FIM total score that eliminated the toileting, bladder management and bowel management items was computed and used in the final analysis with scores ranging from 14-105). The restricted FIM total score was used as the primary outcome measure.
Measured: Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine DysfunctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Cynthia Harrison-Felix, PhD, Craig Hospital
- Investigators
- David Ripley, MD, Principal investigator, Rehab Institute of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201863
- Sponsor's protocol ID
- 10 IHA 11650
- Status last verified
- Jul 2021
- First submitted
- 13 Sep 2010
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ripley DL, Gerber D, Pretz C, Weintraub AH, Wierman ME. Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study. NeuroRehabilitation. 2020;46(3):355-368. doi: 10.3233/NRE-192992.
PubMed 32250330
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
- ClinicalTrials.gov ID
- NCT01201863
- Acronym / sponsor ID
- 10 IHA 11650
- Conditions
- Endocrine Dysfunction, Trauma, Brain Injury
- Keywords
- Testosterone, Traumatic Brain Injury, Hypogonadism, Endocrine Dysfunction, Low Testosterone in men with new Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- Sep 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, double blind, placebo-controlled pilot study assessed the hormonal status of men on admission to an inpatient TBI rehabilitation program. 498 consecutively admitted men for TBI rehabilitation were screened for participation in the study. 22 participants with low T who met all criteria were randomized into placebo (n=10), or physiologic T therapy (n=12). Of those with normal T who met all criteria, 24 were randomized into a follow up group. All participants were evaluated every two weeks for up to 12 weeks: hormone levels, FIM ratings and NIH Toolbox testing as able. There was participant drop out over time as participants were discharged from the hospital. The final analysis examined differences between the normal T, low T Treatment and low T placebo groups on hormone levels, FIM ratings and NIH Toolbox results at baseline and weeks 2, 4 and 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low T Intervention - Androgel Treatment | Experimental | Drug: Androgel (Testosterone Gel)Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to the Androgel treatment group. They underwent hormonal assays, FIM ratings and NIH Toolbox testing at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. |
| Low T Intervention - Placebo Treatment | Placebo comparator | Other: Placebo gelMen with TBI meeting study criteria with Low Testosterone levels were randomly assigned to the Placebo gel treatment group. They underwent hormonal assays, FIM ratings and NIH Toolbox testing at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. |
| Normal T | No intervention | –A subset of men with TBI meeting study criteria with normal T at screening were assessed at all data collection time points to provide a control group. Thirty-eight men obtained normal T levels at screening of which 24 were followed. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- History of TBI as defined as "damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination;"82
- Moderate to severe TBI as indicated by a Glasgow Coma Scale (GCS) score of less than or equal to 12 at emergency department admission, or post traumatic amnesia (PTA) of greater than or equal to seven days post-injury, or radiographic evidence of intracranial injury;
- Continuously hospitalized from time of injury until admission for rehabilitation;
- Enrolled in study within 6 months of TBI;
- Receiving inpatient rehabilitation for TBI at Craig Hospital;
Key exclusion criteria (12 listed)
- History of any conditions that would prohibit testing contained in the NIH toolbox;
- Non-English or non-Spanish speaking (to the extent that would limit the ability to complete study measures);
- History of prior psychiatric illness requiring hospitalization;
- Prior testosterone therapy;
- History of or current or suspected hormonally dependent cancer , including carcinoma of the breast or prostate cancer;
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 |
|---|---|---|
| Androgel (Testosterone Gel)2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g. | Drug | Low T Intervention - Androgel Treatment |
| Placebo gel2.5 gram stickpacks with starting dose of 5g increasing to max of 10g. | Other | Low T Intervention - Placebo Treatment |
Primary outcome
Restricted Functional Independence Measure (FIM)
Time frame: Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.
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 restricted FIM total score that eliminated the toileting, bladder management and bowel management items was computed and used in the final analysis with scores ranging from 14-105). The restricted FIM total score was used as the primary outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32250330Ripley DL, Gerber D, Pretz C, Weintraub AH, Wierman ME. Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study. NeuroRehabilitation. 2020;46(3):355-368. doi: 10.3233/NRE-192992.
- Pubmed link to Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injuryLink provided by the sponsor.
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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.
David Ripley, MD principal investigator
Rehab Institute of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Androgel (Testosterone Gel) in people with Endocrine Dysfunction and Trauma, run by Craig Hospital 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 27 Jul 2021. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Restricted Functional Independence Measure (FIM) (time frame: Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201863, which also lists 1 linked publication.
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 27 Jul 2021.