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NCT04192266 · ClinicalTrials.gov registry record · Phase 3
Estrogen and Fear in PTSD
A Phase 3 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT04192266: Completed Phase 3 study, sponsored by The University of Texas Health Science Center, Houston.
NCT04192266 is a Phase 3 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 83 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04192266, a Phase 3 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if taking a pill of estradiol (E2) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). 80 subjects will take part in this research study across UTHealth Houston and UPenn (40 subjects at each site). Participants will be randomized into one of two groups, PE + E2 or PE + placebo. The study will include preliminary screening and baseline visits, experimental visits, and therapy visits over the course of six weeks. Several follow-up visits will take place.
Primary Outcome
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
Interventions
- DRUG Placebo oral tablet
- DRUG Estradiol
- BEHAVIORAL Prolonged Exposure (PE) therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2024-12-02 |
| Phase | Phase 3 |
What the finished NCT04192266 record still lists
NCT04192266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04192266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04192266 about?
NCT04192266 is a clinical study titled "Estrogen and Fear in PTSD". The purpose of this research study is to determine if taking a pill of estradiol (E2) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). 80 subjects will take part in this research study across UTHealth Hous...
What is the current status of trial NCT04192266?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2020-06-24. Estimated completion is 2024-12-02.
What interventions are being tested in trial NCT04192266?
The interventions under investigation include: Placebo oral tablet (DRUG), Estradiol (DRUG), Prolonged Exposure (PE) therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04192266?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04192266's enrollment target sits among peer trials
83 1751st of 2000 higher than 249 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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