Trial Outcomes & Findings for Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion (NCT NCT01809639)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

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

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Progesterone 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five Progesterone	Placebo Placebo: Standard placebo for 5 days
Overall Study STARTED	18	7
Overall Study COMPLETED	18	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Progesterone n=18 Participants 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five Progesterone	Placebo n=7 Participants Placebo: Standard placebo for 5 days	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Progesterone n=18 Participants 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five Progesterone	Placebo n=7 Participants Placebo: Standard placebo for 5 days
Time (in Days) That a Patient Reports Symptoms From Their Concussion.	7.3 Days Symptomatic Standard Error 8.64	4.5 Days Symptomatic Standard Error 1.97

Adverse Events

Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Lucas

Spartanburg Regional Healthcare System

Phone: 423-309-5646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place