Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809639
• Other study ID #: IRB00021983
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Concussion

Intervention

Drug:
• Progesterone

• Placebo
Standard placebo

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	American Medical Society for Sports Medicine (AMSSM) Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in Days) That a Patient Reports Symptoms From Their Concussion.	The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline.	From date of injury until date asymptomatic, assessed up to 24 months