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Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Concussion

Intervention: Progesterone (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Christopher M Miles, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine
John A Lucas, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine

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.

Clinical Details

Official title: Micronized Oral Progesterone and Effect on Time Symptomatic From Concussion: A Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time (in half days) that a patient reports symptoms from their concussion.

Eligibility

Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Wake Forest University Health Sciences, Winston Salem, North Carolina 27157, United States
Additional Information

Starting date: June 2013
Last updated: December 9, 2014

Page last updated: August 23, 2015

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