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The LOW E2 STUDY- Neuroendocrine Risk Mechanisms for Post-traumatic Stress Disorder in Women

ClinicalTrials.gov · COMPLETED, 2025

127 participants

Abstract

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.

Conditions: PTSD, Trauma.

Primary outcome: Amygdala Response to Fearful Faces Stimuli; Amygdala Response to Fear Conditioning Task; Ventromedial Prefrontal Cortex (vmPFC) Activation During the Fear Extinction Task.

Enrollment: 127 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 127 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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