This trial is active, not recruiting.

Condition concussion
Treatment progesterone
Phase phase 4
Sponsor Wake Forest School of Medicine
Collaborator American Medical Society for Sports Medicine (AMSSM) Foundation
Start date June 2013
End date July 2015
Trial size 40 participants
Trial identifier NCT01809639, WFU Procuss


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
progesterone Prometrium
(Placebo Comparator)

Primary Outcomes

Time (in half days) that a patient reports symptoms from their concussion.
time frame: From date of injury until date asymptomatic, assessed up to 24 months

Eligibility Criteria

Male or female participants from 18 years up to 44 years old.

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

Additional Information

Official title Micronized Oral Progesterone and Effect on Time Symptomatic From Concussion: A Pilot Study
Principal investigator Christopher M Miles, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.