Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Public ClinicalTrials.gov record NCT01143064. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
Study identification
- NCT ID
- NCT01143064
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,195 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2010
- Primary completion
- Feb 28, 2014
- Completion
- Feb 28, 2014
- Last update posted
- Oct 1, 2024
2010 – 2014
United States locations
- U.S. sites
- 53
- U.S. states
- 30
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | — |
| LAC+USC Medical Center | Los Angeles | California | 90033 | — |
| University of California San Diego Medical Center | San Diego | California | 92103 | — |
| Denver Health Medical Center | Denver | Colorado | 80204 | — |
| Christiana Care Health System Hospital | Newark | Delaware | 19718 | — |
| Delray Medical Center | Delray Beach | Florida | 33431 | — |
| Tallahassee Memorial Healthcare | Tallahassee | Florida | 32308 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | — |
| John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| Saint John's Hospital | Springfield | Illinois | 62769 | — |
| Wishard Health Services | Indianapolis | Indiana | 46202 | — |
| Methodist Hospital | Indianapolis | Indiana | 46206 | — |
| Mercy Medical Center | Des Moines | Iowa | 50314 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| LSU Health - Shreveport | Shreveport | Louisiana | 71103 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| St. Mary's of Michigan | Saginaw | Michigan | 48604 | — |
| University of Missouri Health Care | Columbia | Missouri | 65212 | — |
| Truman Medical Center Hospital Hill | Kansas City | Missouri | 64108 | — |
| Lester E. Cox Memorial Hospital | Springfield | Missouri | 65804 | — |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Albany Medical Center Hospital | Albany | New York | 12208 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University-Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| St. Elizabeth Health Center | Youngstown | Ohio | 44501 | — |
| OU Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Hospital & Health Center | Portland | Oregon | 97227 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of South Carolina School of Medicine | Columbia | South Carolina | 29203 | — |
| Johnson City Medical Center | Johnson City | Tennessee | 37604 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Marshall University Joan C. Edwards School of Medicine | Huntington | West Virginia | 25701 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 103 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01143064, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2024 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01143064 live on ClinicalTrials.gov.