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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Concussion
Interventions Drug: Progesterone
Drug: Placebo
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Progesterone Placebo
Hide Arm/Group Description

400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Progesterone

Placebo: Standard placebo for 5 days
Period Title: Overall Study
Started 18 7
Completed 18 7
Not Completed 0 0
Arm/Group Title Progesterone Placebo Total
Hide Arm/Group Description

400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Progesterone

Placebo: Standard placebo for 5 days Total of all reporting groups
Overall Number of Baseline Participants 18 7 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
7
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
Female
0
   0.0%
2
  28.6%
2
   8.0%
Male
18
 100.0%
5
  71.4%
23
  92.0%
1.Primary Outcome
Title Time (in Days) That a Patient Reports Symptoms From Their Concussion.
Hide Description 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.
Time Frame From date of injury until date asymptomatic, assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Placebo
Hide Arm/Group Description:

400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Progesterone

Placebo: Standard placebo for 5 days
Overall Number of Participants Analyzed 18 7
Mean (Standard Error)
Unit of Measure: Days Symptomatic
7.3  (8.64) 4.5  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Progesterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .42
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Progesterone Placebo
Hide Arm/Group Description

400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Progesterone

Placebo: Standard placebo for 5 days
All-Cause Mortality
Progesterone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Progesterone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Progesterone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Lucas
Organization: Spartanburg Regional Healthcare System
Phone: 423-309-5646
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01809639     History of Changes
Other Study ID Numbers: IRB00021983
First Submitted: March 7, 2013
First Posted: March 13, 2013
Results First Submitted: April 28, 2016
Results First Posted: July 14, 2016
Last Update Posted: August 28, 2018