NCT01809639

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Concussion

Interventions

Type	Name	Description
DRUG	Progesterone
DRUG	Placebo	Standard placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-03-13
• Last updated: 2018-08-28
• Results posted: 2016-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study