Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Wake Forest University Health Sciences
Collaborator:
American Medical Society for Sports Medicine (AMSSM) Foundation