PTSD and Trauma-related SymptomsEarly Phase 1EstroFearGenNCT07737613
Acute Effects of Estradiol Administration on Brain Function During Fear Learning
A Early Phase 1 study testing estradiol in people with PTSD and Trauma-related Symptoms and Cognitive Decline in Older Adults, run by University of Arizona.
Trial summary
The goal of current study is to better understand how fear is processed in the brain and how these processes are influenced by cognition and hormones. This research will focus specifically on postmenopausal female adults, because age-related changes in cognition and declining estrogen levels may contribute to anxiety… Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD and Trauma-related Symptoms, Cognitive Decline in Older Adults, Post Menopausal Women
- What is being tested?
- estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- post-menopausal
- normal or corrected-to-normal vision
- English speaking
- stable medication use (no changes in the past three months)
Who cannot join
- use of hormone therapy containing synthetic estrogen
- MRI contraindications (e.g., irremovable ferrous metal in body, claustrophobia)
- history of neurological disorder (including mild cognitive impairment) or moderate to severe traumatic brain injury
- use of antipsychotic, opiate, or mood stabilizer (i.e., lithium) medication
- history of blood clots/deep vein thrombosis, prior stroke or TIA, uncontrolled hypertension
- history of migraine with aura
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- severe liver disease
- history of breast, endometrial, or ovarian cancer
- smoking >10 cigarettes/day
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neuroimaging Study of Fear Learning: Effects of Estrogen
The goal of current study is to better understand how fear is processed in the brain and how these processes are influenced by cognition and hormones. This research will focus specifically on postmenopausal female adults, because age-related changes in cognition and declining estrogen levels may contribute to anxiety symptoms and PTSD risk later in life.
- Conditions
- PTSD and Trauma-related Symptoms, Cognitive Decline in Older Adults, Post Menopausal Women
- Being tested
- estradiol
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiolDrug
Also called Estrace
oral 2mg tablet of estradiol
| Study group | Role | What they receive |
|---|---|---|
| Estradiol | Experimental | single 2mg dose of estradiol by mouth Receives: Drug: estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Response to Fear Conditioning Task
Estrogen has been shown to modulate the function of brain regions involved in fear processing, including the amygdala, hippocampus, and ventromedial prefrontal cortex. During fMRI, participants will complete a fear conditioning and generalization task to measure brain activity. They will view different neutral images of geometric shapes which may or may not predict the imminent receipt of an electric shock to the ankle. Across voxels of the brain, activation estimates (BOLD response) will be extracted for CS+ (conditioned threat) vs. CS- (conditioned safety) cues, and linear activation patterns across ambiguous generalization stimuli (i.e., GSs; CS+ > GS1 > GS2 > GS3 > CS-).
Measured: single visit, approximately 4 hours after taking study drug
Secondary outcomes (2)
Skin Conductance Response
Sweat glands activate under stress, increasing the electrical conductance of the skin. Participants will have electrodes attached on their palm to measure changes in sympathetic nervous system activity, providing an objective, physiological measure of anticipatory anxiety.
Measured: single visit, approximately 4 hours after taking study drug
Subjective Fear and Risk Ratings
Self-report can be used to ascertain subjective fear and explicit knowledge of threat contingencies. Participants will be asked to rate of perceived risk of each displayed stimulus from 1 (no risk) to 3 (high risk), contingency learning, and aversiveness of the stimulation (1-5) during task completion in the scanner and after.
Measured: single visit, approximately 4 hours after taking study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD and Trauma-related SymptomsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Huggins, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737613
- Sponsor's protocol ID
- STUDY00008306
- Acronym
- EstroFearGen
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study of Fear Learning: Effects of Estrogen
- ClinicalTrials.gov ID
- NCT07737613
- Acronym / sponsor ID
- EstroFearGen / STUDY00008306
- Conditions
- PTSD and Trauma-related Symptoms, Cognitive Decline in Older Adults, Post Menopausal Women
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of current study is to better understand how fear is processed in the brain and how these processes are influenced by cognition and hormones. This research will focus specifically on postmenopausal female adults, because age-related changes in cognition and declining estrogen levels may contribute to anxiety symptoms and PTSD risk later in life.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estradiol | Experimental | Drug: estradiolsingle 2mg dose of estradiol by mouth |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- post-menopausal
- normal or corrected-to-normal vision
- English speaking
- stable medication use (no changes in the past three months)
Key exclusion criteria (9 listed)
- use of hormone therapy containing synthetic estrogen
- MRI contraindications (e.g., irremovable ferrous metal in body, claustrophobia)
- history of neurological disorder (including mild cognitive impairment) or moderate to severe traumatic brain injury
- use of antipsychotic, opiate, or mood stabilizer (i.e., lithium) medication
- history of blood clots/deep vein thrombosis, prior stroke or TIA, uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estradiolAlso: Estraceoral 2mg tablet of estradiol | Drug | Estradiol |
Primary outcome
Neural Response to Fear Conditioning Task
Time frame: single visit, approximately 4 hours after taking study drug
Estrogen has been shown to modulate the function of brain regions involved in fear processing, including the amygdala, hippocampus, and ventromedial prefrontal cortex. During fMRI, participants will complete a fear conditioning and generalization task to measure brain activity. They will view different neutral images of geometric shapes which may or may not predict the imminent receipt of an electric shock to the ankle. Across voxels of the brain, activation estimates (BOLD response) will be extracted for CS+ (conditioned threat) vs. CS- (conditioned safety) cues, and linear activation patterns across ambiguous generalization stimuli (i.e., GSs; CS+ > GS1 > GS2 > GS3 > CS-).
2 secondary outcomes
Skin Conductance Response
Time frame: single visit, approximately 4 hours after taking study drug
Subjective Fear and Risk Ratings
Time frame: single visit, approximately 4 hours after taking study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Huggins principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing estradiol in people with PTSD and Trauma-related Symptoms and Cognitive Decline in Older Adults, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Huynh (520-333-5482, nxhuynh@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Response to Fear Conditioning Task (time frame: single visit, approximately 4 hours after taking study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.