Trial Outcomes & Findings for Estrogen and Fear in PTSD (NCT NCT04192266)
NCT ID: NCT04192266
Last Updated: 2026-01-09
Results Overview
Functional Magnetic Resonance Imaging (fMRI) will be used to assess Blood Oxygen Level Dependent (BOLD) signal activation in the amygdala before and after completion of the experimental task. Change in activation will be reported using beta weights; positive beta weights mean greater activation and negative beta weights mean less activation in the specific brain region being monitored
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
83 participants
Primary outcome timeframe
Before and after treatment on Experimental day 2
Results posted on
2026-01-09
Participant Flow
A total of 123 participants were screened for eligibility. Of these, 83 participants met inclusion criteria and were enrolled in the study. Among the enrolled participants, 19 withdrew before randomization. The remaining 64 participants were randomized and began study participation.
Participant milestones
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Estrogen and Fear in PTSD
Baseline characteristics by cohort
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=31 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=33 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=8 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=8 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=8 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=8 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
3 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=8 Participants
|
33 participants
n=7 Participants
|
64 participants
n=15 Participants
|
|
Marital Status
Single
|
23 Participants
n=8 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=15 Participants
|
|
Marital Status
Living with Partner
|
6 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=15 Participants
|
|
Marital Status
Married
|
2 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=15 Participants
|
|
Marital Status
Divorced
|
0 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=15 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Marital Status
Separated
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Marital Status
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Highest Education Level Completed
Graduate School
|
7 Participants
n=8 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=15 Participants
|
|
Highest Education Level Completed
College Graduate
|
11 Participants
n=8 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=15 Participants
|
|
Highest Education Level Completed
Partial College
|
13 Participants
n=8 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=15 Participants
|
|
Highest Education Level Completed
High School Graduate
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Highest Education Level Completed
Partial High School
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Highest Education Level Completed
Junior High School
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Highest Education Level Completed
Less than 7 years of school
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Current Employment Status
Not applicable
|
5 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=15 Participants
|
|
Current Employment Status
Full-time employment
|
11 Participants
n=8 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=15 Participants
|
|
Current Employment Status
Part-time employment
|
5 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=15 Participants
|
|
Current Employment Status
Student/Dependent on spouse
|
10 Participants
n=8 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=15 Participants
|
|
Current Employment Status
Recipient of public/private assistance
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Before and after treatment on Experimental day 2Population: Data were not collected from 4 participants in the Prolonged Exposure (PE) Therapy With Active Pill arm because 3 participants dropped out and 1 participant had data acquisition errors. Data were not collected from 3 participants in the Prolonged Exposure (PE) Therapy With Placebo arm because 2 participants dropped out and 1 participant experienced an adverse event and the visit was not completed.
Functional Magnetic Resonance Imaging (fMRI) will be used to assess Blood Oxygen Level Dependent (BOLD) signal activation in the amygdala before and after completion of the experimental task. Change in activation will be reported using beta weights; positive beta weights mean greater activation and negative beta weights mean less activation in the specific brain region being monitored
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=27 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=30 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in Amygdala Activation as Measured by Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen Level Dependent (BOLD) Signal
|
0.534 beta weights
Standard Error 0.201
|
-0.0037 beta weights
Standard Error 0.159
|
PRIMARY outcome
Timeframe: Before and after treatment on Experimental day 2Population: Data were not collected from 4 participants in the Prolonged Exposure (PE) Therapy With Active Pill arm because 3 participants dropped out and 1 participant had data acquisition errors. Data were not collected from 3 participants in the Prolonged Exposure (PE) Therapy With Placebo arm because 2 participants dropped out and 1 participant experienced an adverse event and the visit was not completed.
Functional Magnetic Resonance Imaging (fMRI) will be used to assess Blood Oxygen Level Dependent (BOLD) signal activation in the dorsal anterior cingulate cortex (dACC) before and after completion of the experimental task. Change in activation will be reported using beta weights; positive beta weights mean greater activation and negative beta weights mean less activation in the specific brain region being monitored
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=27 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=30 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in Dorsal Anterior Cingulate Cortex (dACC) Activation as Measured by Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen Level Dependent (BOLD) Signal
|
0.292 beta weights
Standard Error 0.213
|
-0.0276 beta weights
Standard Error 0.219
|
PRIMARY outcome
Timeframe: Before and after treatment on Experimental day 2Population: Data were not collected from 4 participants in the Prolonged Exposure (PE) Therapy With Active Pill arm because 3 participants dropped out and 1 participant had data acquisition errors. Data were not collected from 3 participants in the Prolonged Exposure (PE) Therapy With Placebo arm because 2 participants dropped out and 1 participant experienced an adverse event and the visit was not completed.
Functional Magnetic Resonance Imaging (fMRI) will be used to assess Blood Oxygen Level Dependent (BOLD) signal activation in the ventromedial prefrontal cortex (vmPFC) before and after completion of the experimental task. Change in activation will be reported using beta weights; positive beta weights mean greater activation and negative beta weights mean less activation in the specific brain region being monitored
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=27 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=30 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in Ventromedial Prefrontal Cortex (vmPFC) Activation as Measured by Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen Level Dependent (BOLD) Signal
|
0.512 beta weights
Standard Error 0.247
|
-0.118 beta weights
Standard Error 0.209
|
PRIMARY outcome
Timeframe: Before and after treatment on Experimental day 2Population: Data were not collected from 4 participants in the Prolonged Exposure (PE) Therapy With Active Pill arm because 3 participants dropped out and 1 participant had data acquisition errors. Data were not collected from 3 participants in the Prolonged Exposure (PE) Therapy With Placebo arm because 2 participants dropped out and 1 participant experienced an adverse event and the visit was not completed.
Functional Magnetic Resonance Imaging (fMRI) will be used to assess Blood Oxygen Level Dependent (BOLD) signal activation in the hippocampus before and after completion of the experimental task. Change in activation will be reported using beta weights; positive beta weights mean greater activation and negative beta weights mean less activation in the specific brain region being monitored.
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=27 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=30 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in Hippocampus Activation as Measured by Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen Level Dependent (BOLD) Signal
|
0.341 beta weights
Standard Error 0.158
|
-0.0606 beta weights
Standard Error 0.178
|
SECONDARY outcome
Timeframe: Pre - Treatment Experimental Day 2 recallPopulation: Data were not collected from 13 participants in the Prolonged Exposure (PE) Therapy With Active Pill arm because 3 participants dropped out, 5 participants had data acquisition errors, and 5 participants had unusable data. Data were not collected from 11 participants in the Prolonged Exposure (PE) Therapy With Placebo arm because 2 dropped out, 2 had data acquisition errors, 1 participant experienced an adverse event and the visit was not completed, and 6 participants had unusable data.
Skin Conductance Response (SCR) assesses the stress/seat level, or level of anxiety in a particular moment, or in response to a specific cue. SCR are reported in microsiemens, a positive value indicates an increase of response to the condition stimulus relative to 3 seconds prior to its onset. A negative value indicates a decrease in response to the condition stimulus relative to 3 seconds prior to its onset.
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=18 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=22 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Skin Conductance Response (SCR) During Recall
|
-0.0741 microsiemens
Standard Deviation 0.0821
|
-0.195 microsiemens
Standard Deviation 0.0659
|
SECONDARY outcome
Timeframe: Post- Treatment Experimental Day 2 recallPopulation: Data were not collected from 13 participants in the Prolonged Exposure (PE) Therapy With Active Pill arm because 3 participants dropped out, 5 participants had data acquisition errors, and 5 participants had unusable data. Data were not collected from 11 participants in the Prolonged Exposure (PE) Therapy With Placebo arm because 2 dropped out, 2 had data acquisition errors, 1 participant experienced an adverse event and the visit was not completed, and 6 participants had unusable data.
Skin Conductance Response (SCR) assesses the stress/seat level, or level of anxiety in a particular moment, or in response to a specific cue. SCR will be reported in microsiemens
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=18 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=22 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Skin Conductance Response (SCR) During Recall
|
0.000479 microsiemens
Standard Deviation 0.0167
|
0.0894 microsiemens
Standard Deviation 0.0457
|
SECONDARY outcome
Timeframe: Baseline, 1 month post interventionPopulation: Data were not collected from 7 participants in the PE therapy with Estradiol arm: 2 dropped out, 2 are missing baseline and post treatment scores because CAPS was not part of the study at the time and 2 are missing baseline scores because CAPS was not part of the study at this time. Data were not collected from 3 participants in the PE therapy with Placebo arm: 2 dropped out and 1 is missing both baseline and post treatment scores because CAPS measure was not part of the study at that time.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS) measures PTSD symptom severity. CAPS has a total score from 0 to 80, with higher scores indicating more severe PTSD symptoms. The change in score will be reported as the \[(Score at 1 month post intervention) - (Score at Baseline)\] - A negative value indicates a reduction in PTSD symptom severity
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=24 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=30 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in PTSD Symptom Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
|
-14.83 score on a scale
Standard Error 1.848
|
-18.23 score on a scale
Standard Error 1.848
|
SECONDARY outcome
Timeframe: Baseline, 3 months post interventionPopulation: Data were not collected from 8 participants in the PE therapy with Estradiol arm: 3 dropped out, 4 are missing baseline scores because CAPS was not part of the study at this time and 1 did not complete the 3 month follow up visit. Data were not collected from 3 participants in the PE therapy with Placebo arm: 2 dropped out and 1 is missing baseline scores because CAPS measure was not part of the study at that time.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS) measures PTSD symptom severity. CAPS has a total score from 0 to 80, with higher scores indicating more severe PTSD symptoms. The change in score will be reported as the \[(Score at 3 month post intervention) - (Score at Baseline)\] - A negative value indicates a reduction in PTSD symptom severity
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=23 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=30 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in PTSD Symptom Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
|
-21.04 score on a scale
Standard Error 1.5572
|
-22.3 score on a scale
Standard Error 1.8944
|
SECONDARY outcome
Timeframe: Baseline, 6 months post interventionPopulation: Data were not collected from 8 participants in the PE therapy with Estradiol arm: 3 dropped out, 4 are missing baseline scores because CAPS was not part of the study at this time and 1 did not complete the 6 month follow up visit. Data were not collected from 4 participants in the PE therapy with Placebo arm: 2 dropped out and 1 is missing baseline scores because CAPS measure was not part of the study at that time and 1 did not complete the 6 month follow up visit.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS) measures PTSD symptom severity. CAPS has a total score from 0 to 80, with higher scores indicating more severe PTSD symptoms. The change in score will be reported as the \[(Score at 6 month post intervention) - (Score at Baseline)\] - A negative value indicates a reduction in PTSD symptom severity
Outcome measures
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=23 Participants
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=29 Participants
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Change in PTSD Symptom Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
|
-22.83 score on a scale
Standard Error 1.7812
|
-23.62 score on a scale
Standard Error 1.9095
|
Adverse Events
Prolonged Exposure (PE) Therapy With Estradiol
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Prolonged Exposure (PE) Therapy With Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prolonged Exposure (PE) Therapy With Estradiol
n=31 participants at risk
A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Estradiol: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
Prolonged Exposure (PE) Therapy With Placebo
n=33 participants at risk
A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
Placebo oral tablet: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
Prolonged Exposure (PE) therapy: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
|
|---|---|---|
|
Gastrointestinal disorders
nausea and/or vomiting and/or diarrhea
|
12.9%
4/31 • Number of events 4 • Up to 6 months
|
12.1%
4/33 • Number of events 4 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID illness or post COVID vaccine symptoms
|
12.9%
4/31 • Number of events 4 • Up to 6 months
|
15.2%
5/33 • Number of events 7 • Up to 6 months
|
|
Psychiatric disorders
Emotional distress, fatigue
|
9.7%
3/31 • Number of events 5 • Up to 6 months
|
6.1%
2/33 • Number of events 3 • Up to 6 months
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Number of events 2 • Up to 6 months
|
9.1%
3/33 • Number of events 4 • Up to 6 months
|
|
Reproductive system and breast disorders
Issues related to menstrual cycle
|
6.5%
2/31 • Number of events 2 • Up to 6 months
|
6.1%
2/33 • Number of events 2 • Up to 6 months
|
|
Injury, poisoning and procedural complications
Arm bruising and ache
|
6.5%
2/31 • Number of events 2 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
Injury, poisoning and procedural complications
Injury
|
3.2%
1/31 • Number of events 2 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
Social circumstances
General distress due to Interpersonal Conflict
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
Reproductive system and breast disorders
Changes in libido
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
General disorders
Weight gain
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
Reproductive system and breast disorders
Polyp in uterus found after routine medical checkup
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
Nervous system disorders
Concussion
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
General disorders
Allergic Reaction
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
Nervous system disorders
Brain fog and nausea
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
General disorders
Fever, nausea, and insomnia
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
Gastrointestinal disorders
Gastrointestinal illness
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
Immune system disorders
Lymphangitis
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
|
General disorders
Neck pain
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
Nervous system disorders
Tremulousness, headache, nausea
|
3.2%
1/31 • Number of events 1 • Up to 6 months
|
0.00%
0/33 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/31 • Up to 6 months
|
3.0%
1/33 • Number of events 1 • Up to 6 months
|
Additional Information
Mohammed R Milad, PhD
The University of Texas Health Science Center at Houston
Phone: 713-486-2754
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place