Severe Head TraumaPhase 1NCT06631547
Effect of Progesterone Administration on Severely Head Injured Patients
A Phase 1 study testing Progesterone and The usual head trauma care in people with Severe Head Trauma, run by Assiut University.
Trial summary
To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Severe Head Trauma
- What is being tested?
- Progesterone and The usual head trauma care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jul 2027
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -Tumor that may flare with progesterone.
- patients with spinal injuries with neurological deficits.
- severe chest trauma that causes shock and hypoxia.
- life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest
- pegnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Progesterone Administration on Severely Head Injured Patients: Hospital Based Study
To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome
- Conditions
- Severe Head Trauma
- Being tested
- Progesterone, The usual head trauma care
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Hormonal treatment
The usual head trauma careDrug
the basic treatment
| Study group | Role | What they receive |
|---|---|---|
| patients with main lines of management without progesterone | Placebo comparator | patients with main lines of management without progesterone Receives: Drug: The usual head trauma care |
| Patients taking progesterone plus the main lines of management of traumatic brain injury | Active comparator | taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury Receives: Drug: Progesterone; Drug: The usual head trauma care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow outcome scale GOS-E score
as thhe following:1-indicates death 2-indicates a vegetative state, 3 or 4 indicates a severe disability, 5 or 6 indicates a moderate disability and 7 or 8 indicates a good recovery. (8, 9)
Measured: 1year
FIM score
is available measure of dependence in two subscales (motor and cognitive) (10) . Motor domains self care (eating, grooming, bathing, body upper dressing, body lower dressing, swallowing, moving to bed and chair, toileting
Measured: 1 year
Secondary outcomes (5)
mortality rate
death rate at 1 month
Measured: 1 month
Duration of hospital stay
Duration of hospital stay
Measured: 1month
Duration of mechanical ventilator
Duration of mechanical ventilator
Measured: 1month
adverse events
adverse events
Measured: 1 month
Gcs
Gcs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Severe Head TraumaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intramuscular injection of progesterone
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Abd El Aal Helmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631547
- Sponsor's protocol ID
- Pgs in head trauma
- Status last verified
- Jun 2025
- First submitted
- 4 Oct 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brooks JC, Strauss DJ, Shavelle RM, Paculdo DR, Hammond FM, Harrison-Felix CL. Long-term disability and survival in traumatic brain injury: results from the National Institute on Disability and Rehabilitation Research Model Systems. Arch Phys Med Rehabil. 2013 Nov;94(11):2203-9. doi: 10.1016/j.apmr.2013.07.005. Epub 2013 Jul 16.
PubMed 23872079Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
PubMed 9726257Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. doi: 10.1016/s0140-6736(75)92830-5.
PubMed 46957Sarkaki AR, Khaksari Haddad M, Soltani Z, Shahrokhi N, Mahmoodi M. Time- and dose-dependent neuroprotective effects of sex steroid hormones on inflammatory cytokines after a traumatic brain injury. J Neurotrauma. 2013 Jan 1;30(1):47-54. doi: 10.1089/neu.2010.1686. Epub 2012 Nov 16.
PubMed 21851230Finnie JW. Neuroinflammation: beneficial and detrimental effects after traumatic brain injury. Inflammopharmacology. 2013 Aug;21(4):309-20. doi: 10.1007/s10787-012-0164-2. Epub 2013 Jan 8.
PubMed 23296919VanLandingham JW, Cekic M, Cutler S, Hoffman SW, Stein DG. Neurosteroids reduce inflammation after TBI through CD55 induction. Neurosci Lett. 2007 Sep 25;425(2):94-8. doi: 10.1016/j.neulet.2007.08.045. Epub 2007 Aug 25.
PubMed 17826908Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271.
PubMed 32722286Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.
PubMed 17573392Thapa K, Khan H, Singh TG, Kaur A. Traumatic Brain Injury: Mechanistic Insight on Pathophysiology and Potential Therapeutic Targets. J Mol Neurosci. 2021 Sep;71(9):1725-1742. doi: 10.1007/s12031-021-01841-7. Epub 2021 May 6.
PubMed 33956297Management of Concussion/mTBI Working Group. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. J Rehabil Res Dev. 2009;46(6):CP1-68. No abstract available.
PubMed 20108447
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progesterone Administration on Severely Head Injured Patients: Hospital Based Study
- ClinicalTrials.gov ID
- NCT06631547
- Acronym / sponsor ID
- Pgs in head trauma
- Conditions
- Severe Head Trauma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Oct 2024 (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.
To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intramuscular injection of progesterone
| Arm | Type | Receives |
|---|---|---|
| patients with main lines of management without progesterone | Placebo comparator | Drug: The usual head trauma carepatients with main lines of management without progesterone |
| Patients taking progesterone plus the main lines of management of traumatic brain injury | Active comparator | Drug: Progesterone, Drug: The usual head trauma caretaking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- -Tumor that may flare with progesterone.
- patients with spinal injuries with neurological deficits.
- severe chest trauma that causes shock and hypoxia.
- life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest
- pegnancy
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 |
|---|---|---|
| ProgesteroneHormonal treatment | Drug | Patients taking progesterone plus the main lines of management of traumatic brain injury |
| The usual head trauma carethe basic treatment | Drug | Patients taking progesterone plus the main lines of management of traumatic brain injury, patients with main lines of management without progesterone |
Primary outcome
Glasgow outcome scale GOS-E score
Time frame: 1year
as thhe following:1-indicates death 2-indicates a vegetative state, 3 or 4 indicates a severe disability, 5 or 6 indicates a moderate disability and 7 or 8 indicates a good recovery. (8, 9)
FIM score
Time frame: 1 year
is available measure of dependence in two subscales (motor and cognitive) (10) . Motor domains self care (eating, grooming, bathing, body upper dressing, body lower dressing, swallowing, moving to bed and chair, toileting
5 secondary outcomes
mortality rate
Time frame: 1 month
Duration of hospital stay
Time frame: 1month
Duration of mechanical ventilator
Time frame: 1month
adverse events
Time frame: 1 month
Gcs
Time frame: 1 year
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 25 Jun 2025.
- Results publication: PubMed 23872079Brooks JC, Strauss DJ, Shavelle RM, Paculdo DR, Hammond FM, Harrison-Felix CL. Long-term disability and survival in traumatic brain injury: results from the National Institute on Disability and Rehabilitation Research Model Systems. Arch Phys Med Rehabil. 2013 Nov;94(11):2203-9. doi: 10.1016/j.apmr.2013.07.005. Epub 2013 Jul 16.
- Results publication: PubMed 9726257Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
- Results publication: PubMed 46957Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. doi: 10.1016/s0140-6736(75)92830-5.
- Results publication: PubMed 21851230Sarkaki AR, Khaksari Haddad M, Soltani Z, Shahrokhi N, Mahmoodi M. Time- and dose-dependent neuroprotective effects of sex steroid hormones on inflammatory cytokines after a traumatic brain injury. J Neurotrauma. 2013 Jan 1;30(1):47-54. doi: 10.1089/neu.2010.1686. Epub 2012 Nov 16.
- Results publication: PubMed 23296919Finnie JW. Neuroinflammation: beneficial and detrimental effects after traumatic brain injury. Inflammopharmacology. 2013 Aug;21(4):309-20. doi: 10.1007/s10787-012-0164-2. Epub 2013 Jan 8.
- Results publication: PubMed 17826908VanLandingham JW, Cekic M, Cutler S, Hoffman SW, Stein DG. Neurosteroids reduce inflammation after TBI through CD55 induction. Neurosci Lett. 2007 Sep 25;425(2):94-8. doi: 10.1016/j.neulet.2007.08.045. Epub 2007 Aug 25.
- Results publication: PubMed 32722286Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271.
- Results publication: PubMed 17573392Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.
- Results publication: PubMed 33956297Thapa K, Khan H, Singh TG, Kaur A. Traumatic Brain Injury: Mechanistic Insight on Pathophysiology and Potential Therapeutic Targets. J Mol Neurosci. 2021 Sep;71(9):1725-1742. doi: 10.1007/s12031-021-01841-7. Epub 2021 May 6.
- Results publication: PubMed 20108447Management of Concussion/mTBI Working Group. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. J Rehabil Res Dev. 2009;46(6):CP1-68. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesterone and The usual head trauma care in people with Severe Head Trauma, run by Assiut University.
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 0 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Contact Islam Abd El Aal Helmy (+20 1068825066, islamabdelal3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow outcome scale GOS-E score (time frame: 1year). The study lists 2 primary outcomes in all. 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 NCT06631547, which also lists 10 linked publications.
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 25 Jun 2025.