Trial · NCT00822900

Progesterone for the Treatment of Traumatic Brain Injury III

NCT00822900, Phase 3, Terminated, David Wright; results first posted 2015-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Progesterone for the Treatment of Traumatic Brain Injury III. Trials, record NCT00822900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00822900

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Progesterone for the Treatment of Traumatic Brain Injury III
NCT number: NCT00822900
Status: Terminated
Phases: Phase 3
Enrollment: 882 participants, actual
Lead sponsor: David Wright
Conditions: Traumatic Brain Injury
Interventions: Progesterone, Placebo
First posted: 2009-01-15
Last updated: 2016-01-20
Results first posted: 2015-07-03
Limitations and caveats: The trial was stopped early for futility with respect to the primary outcome.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	6 months post randomization	A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.
Secondary	Mortality	6 months
Secondary	Disability Rating Scale	6 months	A measure of functional impairment, with complete recovery scored a 0 and vegetative state scored a 29.
Secondary	Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis	within 6 months	Phlebitis/Thrombophlebitis (not due to infiltration or misplacement of the IV)
Secondary	Potentially Associated Adverse Events: Pulmonary Embolism	within 6 months	Pulmonary embolism - Events were defined based on either positive chest computed tomography (CT) scanning or ventilation/perfusion lung scan (V/Q).
Secondary	Potentially Associated Adverse Events: Acute Ischemic Stroke	within 6 months	Acute ischemic stroke - Events were defined based on either positive computed tomography (CT) scanning, magnetic resonance imaging (MRI), or neurologist diagnosis of cerebrovascular accident (CVA)
Secondary	Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)	within 6 months	DVT - Events were defined based on a positive Doppler ultrasound exam
Secondary	Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level	within 6 months	Unexplained increased liver enzymes (e.g. not due to liver injury ) - Events were defined based on aspartate transaminase (AST) and alanine transaminase (ALT) levels \> 500 U/L and/or total bilirubin levels \> 2.0 mg/dL.
Secondary	Potentially Associated Adverse Events: Sepsis	within 6 months	Sepsis - Events must have met Centers for Disease Control and Prevention (CDC) definition of sepsis. The definition includes that a patient ≤1 year of age has at least 1 of the following clinical signs or symptoms with no other recognized cause: fever (\>38°C rectal), hypothermia (\<37°C rectal), apnea, or bradycardia, and blood culture not done or no organisms detected in blood and no apparent infection at another site and physician institutes treatment for sepsis.
Secondary	Potentially Associated Adverse Events: Pneumonia	within 6 months	Events must have met Centers for Disease Control and Prevention (CDC) definition of pneumonia. There are three specific types of pneumonia: clinically defined pneumonia, pneumonia with specific laboratory findings, and pneumonia in immunocompromised patients. There are specific algorithms to identify each pneumonia, which include x-ray findings, fever with no other cause, leukopenia or leukocytosis, altered mental status with no other cause (adults \>70 years old), new onset of purulent sputum, change in character of sputum, increase respiratory secretions, increase suctioning requirements, new onset or worsening cough, dyspnea, tachypnea, rales, bronchial breath sounds, or worsening gas exchange, increased oxygen requirements, or increased ventilator demand). Also, labs can identify pneumonia such as positive growth in blood culture, positive Gram stain, and histopathologic exam evidence.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	6 months post randomization	The primary analysis was conducted according to intention to treat.	participants	NUMBER
SECONDARY	Mortality	6 months		participants	NUMBER
SECONDARY	Disability Rating Scale	6 months		units on a scale	MEAN
SECONDARY	Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis	within 6 months		participants	NUMBER
SECONDARY	Potentially Associated Adverse Events: Pulmonary Embolism	within 6 months		participants	NUMBER
SECONDARY	Potentially Associated Adverse Events: Acute Ischemic Stroke	within 6 months		participants	NUMBER
SECONDARY	Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)	within 6 months		participants	NUMBER
SECONDARY	Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level	within 6 months		participants	NUMBER
SECONDARY	Potentially Associated Adverse Events: Sepsis	within 6 months		participants	NUMBER
SECONDARY	Potentially Associated Adverse Events: Pneumonia	within 6 months		participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	Progesterone	Favorable Outcome	213	participants
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	Placebo	Favorable Outcome	232	participants
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	Progesterone	Unfavorable	201	participants
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	Placebo	Unfavorable	184	participants
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	Progesterone	Missing Data	28	participants
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)	Placebo	Missing Data	24	participants
Mortality	Progesterone	Subjects with events	83	participants
Mortality	Placebo	Subjects with events	69	participants
Mortality	Progesterone	Subjects without events	359	participants
Mortality	Placebo	Subjects without events	371	participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Progesterone	442
Overall Study	STARTED	Placebo	440
Overall Study	COMPLETED	Progesterone	334
Overall Study	COMPLETED	Placebo	347
Overall Study	NOT COMPLETED	Progesterone	108
Overall Study	NOT COMPLETED	Placebo	93

Source ClinicalTrials.gov

Adverse events630

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Progesterone	8	442	9
other	Anemia	Blood and lymphatic system disorders	Placebo	11	440	12
other	Coagulopathy	Blood and lymphatic system disorders	Progesterone	3	442	3
other	Coagulopathy	Blood and lymphatic system disorders	Placebo	1	440	1
other	Leukocytosis	Blood and lymphatic system disorders	Progesterone	12	442	13
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	6	440	6
other	Thrombocytopenia	Blood and lymphatic system disorders	Progesterone	4	442	5
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	7	440	7
other	Thrombocytosis	Blood and lymphatic system disorders	Progesterone	0	442	0
other	Thrombocytosis	Blood and lymphatic system disorders	Placebo	3	440	3

1 to 10 of 630Source ClinicalTrials.gov

See all 630 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Progesterone
Total, all-cause mortality	Placebo
Total, other adverse events	Progesterone	332	442
Total, other adverse events	Placebo	330	440
Total, serious adverse events	Progesterone	246	442
Total, serious adverse events	Placebo	251	440

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25493974	DERIVED	PubMed
26464429	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Progesterone vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00822900

GET https://conductscience.org/api/trials/v1/NCT00822900/results?page=2

API reference For AI assistants