Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Progesterone

400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Standard placebo

Interventions

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Progesterone

Intervention Type DRUG

Placebo

Standard placebo

Intervention Type DRUG

Other Intervention Names

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Prometrium

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with a concussion
* A 18 years or older
* Diagnosis \< 24 hours from injury
* Consent obtained prior to concussion

Exclusion Criteria

* Pregnant
* Active breast or reproductive organ cancers
* Allergy to peanuts
* History of or current thrombophlebitis or venous thromboembolic disorder
* Females taking birth control
* Known hypersensitivity or prior adverse reaction to progesterone
* Known liver disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No