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OpenTrials
Completed

NCT Number: NCT01809639

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

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.

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Key information

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone

Drug

Other names: Prometrium

Placebo

Drug

Standard placebo

Primary outcomes

  1. Time (in Days) That a Patient Reports Symptoms From Their Concussion.

    Time frame: From date of injury until date asymptomatic, assessed up to 24 months

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • American Medical Society for Sports Medicine

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2013
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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