CClinicalTrials.gg
Status unknownNCT04426487Updated Jun 11, 2020

Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler

An Early Phase 1 interventional study of Progesterone in Traumatic Brain Injury, sponsored by Minia University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Minia University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .

Read the detailed description

Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • Progesterone
  • Transcranial doppler
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 200 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Traumatic subarachinoid hemorrhage

Exclusion criteria

Exclusion Criteria:

  • History of malignency

    • History of cerebrovasculer stroke
    • Morbid obese
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
200 participants (estimated)

Study arms

  • Placebo comparator
    Control

    Receiving conventional management for traumatic subarachinoid hemorrhage

    Drug: Progesterone

  • Active comparator
    progesterone group

    Intramusculer progesterone therapy before and after craniotomy

    Drug: Progesterone

Interventions

  • DrugProgesterone

    Intramusculer progesterone

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What researchers measure

Primary outcomes

  1. Number of participants suffering neuronal infarction

    Transcranial doppler

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • ElMinia University
    Minya, Abohelal 6115, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04426487
Lead sponsor
Minia University
Responsible party
Mina Maher (Principle investigator, Ministry of Health and Population, Egypt) — Principal investigator
First posted
Jun 11, 2020
Start date
Jun 20, 2020 (estimated)
Primary completion
Sep 1, 2020 (estimated)
Completion
Oct 30, 2020 (estimated)
Last update
Jun 11, 2020

Study contacts

Mina Raouf, MD
Contact
drmina2015@gmail.com
01015752424
Hany Mikhail, MD
study director · Faculty of medicine. ElMinia University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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