Effect of Progesterone Administration on Severely Head Injured Patients

NCT06631547 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pgs in head trauma
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome

Conditions

Severe Head Trauma

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  1 year

Secondary Outcomes (5)

• mortality rate

  1 month

• Duration of hospital stay

  1month

• Duration of mechanical ventilator

  1month

• adverse events

  1 month

• Gcs

  1 year

Study Arms (2)

patients with main lines of management without progesterone

PLACEBO COMPARATOR

patients with main lines of management without progesterone

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

Drug: Progesterone; Drug: The usual head trauma care

Interventions

Progesterone DRUG

Hormonal treatment

Patients taking progesterone plus the main lines of management of traumatic brain injury

The usual head trauma care DRUG

the basic treatment

Patients taking progesterone plus the main lines of management of traumatic brain injury; patients with main lines of management without progesterone

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>16yrs,

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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.

  PMID: 23872079 BACKGROUND

• Wilson 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.

  PMID: 9726257 BACKGROUND

• Jennett 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.

  PMID: 46957 BACKGROUND

• Sarkaki 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.

  PMID: 21851230 BACKGROUND

• Finnie 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.

  PMID: 23296919 BACKGROUND

• VanLandingham 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.

  PMID: 17826908 BACKGROUND

• Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271.

  PMID: 32722286 BACKGROUND

• Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.

  PMID: 17573392 BACKGROUND

• Thapa 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.

  PMID: 33956297 BACKGROUND

• Department Of Defense Washington DC. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury (mTBI). Ft. Belvoir: Defense Technical Information Center; 2009

  BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Islam Abd El Aal Helmy

CONTACT

+20 1068825066; islamabdelal3@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Intramuscular injection of progesterone

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06