Trial · NCT01143064
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
NCT01143064, Phase 3, Completed, BHR Pharma, LLC; results first posted 2024-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury. Trials, record NCT01143064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01143064
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
- NCT number
- NCT01143064
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,195 participants, actual
- Lead sponsor
- BHR Pharma, LLC
- Conditions
- Brain Injuries
- Interventions
- Progesterone, Lipid emulsion without progesterone
- First posted
- 2010-06-14
- Last updated
- 2024-10-02
- Other registries' IDs
- eudract:2010-018283-16
- Results first posted
- 2024-10-02
- Limitations and caveats
Treatment Emergent Adverse Events with Incidence of \>5% by System Organ Class and Preferred Term (Safety Population) data was reported in the Other (Not Including Serious) Adverse Events section. Adverse events were reported for the modified Intention-to-Treat (mITT) population which includes all subjects who were randomized and in whom treatment with study drug was initiated (analyzed according to randomized treatment).
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glasgow Outcome Scale (GOS) | 6 months | The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead. |
| Secondary | Mortality at Month 1 | 1 month post injury | The mortality rate at one month will be compared between the two treatment groups. |
| Secondary | Mortality at Month 6 | 6 months post injury | The mortality rate at six months will be compared between the two treatment groups. |
| Secondary | Glasgow Outcome Scale at 3 Months | Month 3 | The GOS assesses the mortality and disability in traumatic brain injury patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State, or Dead. |
| Secondary | Glasgow Outcome Scale - Extended (GOS-E) | 3 months and 6 months post injury | The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories: * Dead * Vegetative State * Lower Severe Disability * Upper Severe Disability * Lower Moderate Disability * Upper Moderate Disability * Lower Good Recovery * Upper Good Recovery |
| Secondary | Short Form (36) Health Survey (SF-36) | 3 months and 6 months post injury | The Short Form (36) Health Survey (SF-36) is a validated survey of patient health consisting of eight scaled scores which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, role physical, role emotional, role mental and mental health. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| Secondary | Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL) | Admission through post-infusion Day 6 | Cerebral Perfusion Pressure (CPP) levels are presented according to clinically significant cut-off values. CPP was calculated from intracranial pressures and mean arterial pressures measured from Day through Day 6 after initiation of study medication, if an ICP monitor was in place. Specific therapies received during Days 1-6 are summarized according to the Therapeutic Intensity Level (TIL) by treatment group, as maximum level of therapy administered to the subject. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glasgow Outcome Scale (GOS) | 6 months | Only participants with data for this outcome are included. Missing values are first imputed by carrying forward the Month 3 GOS assessment. If a subject has neither the 3 nor the 6 month GOS, the missing value is imputed using the proportional odds model. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality at Month 1 | 1 month post injury | P-value population size is based on the number of subjects with status = alive or dead, month 6 within the mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality at Month 6 | 6 months post injury | P-value population size is based on the number of subjects with status = alive or dead, month 6 within the mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Glasgow Outcome Scale at 3 Months | Month 3 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Glasgow Outcome Scale - Extended (GOS-E) | 3 months and 6 months post injury | Number analyzed (591 for BHR-100 and 588 for placebo) is as listed in the clinical study report. The number analyzed was not modified per time frame and outcome, rather 591 and 588 are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Short Form (36) Health Survey (SF-36) | 3 months and 6 months post injury | Only participants with data for these parameters have been included. | score on a scale | MEAN |
| SECONDARY | Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL) | Admission through post-infusion Day 6 | Only participants with data for these parameters have been included. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glasgow Outcome Scale (GOS) | BHR-100 | Good Recovery | 189 | Participants | |
| Glasgow Outcome Scale (GOS) | Placebo | Good Recovery | 183 | Participants | |
| Glasgow Outcome Scale (GOS) | BHR-100 | Moderate Disability | 109 | Participants | |
| Glasgow Outcome Scale (GOS) | Placebo | Moderate Disability | 114 | Participants | |
| Glasgow Outcome Scale (GOS) | BHR-100 | Severe Disability | 162 | Participants | |
| Glasgow Outcome Scale (GOS) | Placebo | Severe Disability | 160 | Participants | |
| Glasgow Outcome Scale (GOS) | BHR-100 | Vegetative State/Dead | 131 | Participants | |
| Glasgow Outcome Scale (GOS) | Placebo | Vegetative State/Dead | 131 | Participants | |
| Mortality at Month 1 | BHR-100 | Lost to Follow-up | 0 | Participants | |
| Mortality at Month 1 | Placebo | Lost to Follow-up | 0 | Participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BHR-100 | 597 | |
| Overall Study | STARTED | Placebo | 598 | |
| Overall Study | COMPLETED | BHR-100 | 464 | |
| Overall Study | COMPLETED | Placebo | 483 | |
| Overall Study | NOT COMPLETED | BHR-100 | 133 | |
| Overall Study | NOT COMPLETED | Placebo | 115 |
Source ClinicalTrials.gov
Adverse events76
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 | Pyrexia | General disorders | BHR-100 | 209 | 596 | |
| other | Pyrexia | General disorders | Placebo | 229 | 583 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | BHR-100 | 94 | 596 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo | 126 | 583 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | BHR-100 | 86 | 596 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Placebo | 85 | 583 | |
| other | Hyponatraemia | Metabolism and nutrition disorders | BHR-100 | 59 | 596 | |
| other | Hyponatraemia | Metabolism and nutrition disorders | Placebo | 64 | 583 | |
| other | Hypophosphataemia | Metabolism and nutrition disorders | BHR-100 | 32 | 596 | |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Placebo | 49 | 583 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BHR-100 | 109 | 596 |
| Total, all-cause mortality | Placebo | 95 | 583 |
| Total, other adverse events | BHR-100 | 265 | 596 |
| Total, other adverse events | Placebo | 286 | 583 |
| Total, serious adverse events | BHR-100 | 224 | 596 |
| Total, serious adverse events | Placebo | 214 | 583 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BHR-100 vs Placebo: deaths from any cause | Trial comparisons |
| BHR-100 vs Placebo: serious adverse events | 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.
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/NCT01143064
GET https://conductscience.org/api/trials/v1/NCT01143064/results?page=2