Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Completed · Phase 4 · Has a placebo group

Conditions studied: Concussion

In brief

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.

Key facts

Study ID

NCT01809639

Run by

Wake Forest University Health Sciences

People needed

25

Starts

2013-06-01

Expected to finish

2015-12-01

Last updated by the study team

2018-08-28

Who can join

Age: 18 and older, up to 44. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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