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| Name | Class |
|---|---|
| American Medical Society for Sports Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Experimental | 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time (in Days) That a Patient Reports Symptoms From Their Concussion. | The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline. | From date of injury until date asymptomatic, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Miles, MD | Wake Forest University Health Sciences | Principal Investigator |
| John A Lucas, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Progesterone | 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five Progesterone |
| FG001 | Placebo | Placebo: Standard placebo for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Progesterone | 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five Progesterone |
| BG001 | Placebo | Placebo: Standard placebo for 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time (in Days) That a Patient Reports Symptoms From Their Concussion. | The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline. | Posted | Mean | Standard Error | Days Symptomatic | From date of injury until date asymptomatic, assessed up to 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progesterone | 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five Progesterone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Lucas | Spartanburg Regional Healthcare System | 423-309-5646 | jlucas@srhs.com |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Standard placebo |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | Placebo: Standard placebo for 5 days | 0 | 7 | 0 | 7 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |