CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01809639
NCT01809639Phase 4Completed

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

Wake Forest University Health Sciences·interventional·Posted Mar 13, 2013·Updated Aug 28, 2018

In Brief

A Phase 4 clinical trial evaluating Progesterone and Placebo for Concussion. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConcussion
CountriesUnited States

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2013
Enrollment StartJun 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.3 years ago

Interventions

Progesteronedrug

Placebodrug

Standard placebo