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NCT03973229 · ClinicalTrials.gov registry record · Early Phase 1
Neuroendocrine Risk for PTSD in Women
A Early Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 250
- Enrollment target
NCT03973229: Completed Early Phase 1 study, sponsored by Emory University.
NCT03973229 is a Early Phase 1 study that has completed, run by Emory University. The registered enrollment target is 250 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (372% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03973229, a Early Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 250 participants
- Enrollment target
Study Summary
This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early follicular phase and luteal phase): 1. PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD 2. Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD 3. Healthy Control (HC): Women matched for age, but without trauma history or psychiatric disorder (self-reported) Women will be recruited through Grady Trauma Project (GTP), a large longstanding study of civilian trauma and PTSD conducted at Grady Memorial Hospital in Atlanta, Georgia.
Primary Outcome
Responses to threat cues are assessed by functional magnetic resonance imaging (fMRI) responses as participants view 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity is measured. The amygdala is separated in the right and left hemispheres, and subdivided into the basolateral amygdala and central amygdala. Across voxels in each region a contrast estimate of Fearful \> Neutral faces was extracted. The contrast estimate is a standard reporting format for task-based
Interventions
- DRUG Estradiol patch
- OTHER Placebo patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2019-11-11 |
| Est. Completion | 2025-04-30 |
| Phase | Early Phase 1 |
What the finished NCT03973229 record still lists
NCT03973229 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (372% higher).
The record links to 0 conditions, and to 2 interventions - of which Estradiol patch is the first listed.
NCT03973229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03973229 about?
NCT03973229 is a clinical study titled "Neuroendocrine Risk for PTSD in Women". This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early f...
What is the current status of trial NCT03973229?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 250 participants. The study started on 2019-11-11. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT03973229?
The interventions under investigation include: Estradiol patch (DRUG), Placebo patch (OTHER).
Who is sponsoring clinical trial NCT03973229?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03973229's enrollment target sits among peer trials
250 44th of 2000 higher than 1,955 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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