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Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

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ClinicalTrials.gov Identifier: NCT01809639
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : July 14, 2016
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
American Medical Society for Sports Medicine (AMSSM) Foundation
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Concussion Drug: Progesterone Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Micronized Oral Progesterone and Effect on Time Symptomatic From Concussion: A Pilot Study
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progesterone
400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
Drug: Progesterone
Other Name: Prometrium

Placebo Comparator: Placebo Drug: Placebo
Standard placebo




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809639


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
American Medical Society for Sports Medicine (AMSSM) Foundation
Investigators
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Principal Investigator: Christopher M Miles, MD Wake Forest University Health Sciences
Principal Investigator: John A Lucas, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01809639     History of Changes
Other Study ID Numbers: IRB00021983
First Posted: March 13, 2013    Key Record Dates
Results First Posted: July 14, 2016
Last Update Posted: August 28, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Concussion
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs