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NCT01809639 · ClinicalTrials.gov registry record · Phase 4
Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion
A Phase 4 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT01809639 is a Phase 4 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants.
The verdict
NCT01809639, a Phase 4 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
Concussions are a common injury among athletes in the United States. The annual incidence of sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8 million, and the likelihood of an athlete in a contact sport experiencing a concussion is as high as 20 percent per season. Even mild traumatic brain injury, including concussion, can cause long-term cognitive problems that affect a person's ability to perform daily activities and to return to school or work. Far more concerning is the mounting body of evidence that concussions are not just transient injuries - but have cumulative effects. It has been well established in animal models that progesterone has neuroprotective benefits. Animal studies using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema, reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral outcomes. To date, there have been no studies to assess whether or not progesterone will be effective for the treatment of concussions. This double-blind placebo controlled trial will assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize that athletes treated with progesterone will have faster resolution of their concussive symptoms. The investigators believe this study may be the first clinical trial to show an effective treatment for concussion.
Interventions
- DRUG Placebo
- DRUG Progesterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01809639
The ClinicalTrials.gov registry entry for NCT01809639 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01809639 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01809639 about?
NCT01809639 is a clinical study titled "Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion". Concussions are a common injury among athletes in the United States. The annual incidence of sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8 million, and the likelihood of an athlete in a contact sport experiencing a concussion is as high as 20 percent per...
What is the current status of trial NCT01809639?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2013-06. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01809639?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG).
Who is sponsoring clinical trial NCT01809639?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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