Status:
COMPLETED
Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
American Medical Society for Sports Medicine (AMSSM) Foundation
Conditions:
Concussion
Eligibility:
All Genders
18-44 years
Phase:
PHASE4
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 th...
Eligibility Criteria
Inclusion
- Diagnosed with a concussion
- A 18 years or older
- Diagnosis \< 24 hours from injury
- Consent obtained prior to concussion
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01809639
Start Date
June 1 2013
End Date
December 1 2015
Last Update
August 28 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157