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Hormone Therapy

Estradiol Patch for Post-Traumatic Stress Disorder

Phase < 1
Recruiting
Led By Jennifer Stevens, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a smart phone and willing to install the Clue app
African American women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mid-cycle second cycle, mid-cycle third cycle (each cycle is an average of 28 days)
Awards & highlights

Study Summary

This trial will test the effects of estradiol on PTSD symptoms and stress vulnerability in three groups of women.

Who is the study for?
This trial is for African American women who have had a menstrual period in the last 60 days and are not on hormonal birth control. It includes those with PTSD, trauma-exposed without PTSD, and healthy controls without trauma history. Participants must consent to use the Clue app on their smartphone.Check my eligibility
What is being tested?
The study tests if an estradiol (E2) patch affects PTSD symptoms and brain responses to stress in women, compared to a placebo. Women will be grouped by their menstrual cycle phase and whether they have PTSD, exposure to trauma, or neither.See study design
What are the potential side effects?
Possible side effects of the estradiol patch may include skin irritation at the application site, changes in mood or libido, headaches, breast tenderness, nausea, and potential increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a smartphone and am willing to install the Clue app.
Select...
I am an African American woman.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mid-cycle second cycle, mid-cycle third cycle (each cycle is an average of 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and mid-cycle second cycle, mid-cycle third cycle (each cycle is an average of 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in amygdala response to fear conditioning task
Change in amygdala response to fearful faces stimuli
Change in ventromedial prefrontal cortex (vmPFC) activation during the fear extinction task
Secondary outcome measures
Change in Beck Depression Inventory (BDI)
Change in PTSD checklist for DSM-5 (PCL-5)

Side effects data

From 2021 Phase 1 trial • 12 Patients • NCT03681691
50%
Breast Tenderness/Soreness
25%
Elevated Blood Pressure
25%
Started Period-Like Bleeding/Spotting
25%
Cramping
25%
Itching Around Drug Patch
100%
80%
60%
40%
20%
0%
Study treatment Arm
Post Menopausal Women Without Diabetes
Post Menopausal Women With Diabetes

Trial Design

12Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2: PTSD Receiving Placebo then EstradiolExperimental Treatment2 Interventions
Participants with PTSD will begin daily urine ovulation tests on Day 11 of their first cycle, and will record the results with the Clue app. During the second month of cycle monitoring, the MRI will be scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they will use the placebo patch before getting the MRI. They will apply the estradiol patch during the third cycle.
Group II: Cohort 2: PTSD Receiving Estradiol then PlaceboExperimental Treatment2 Interventions
Participants with PTSD will begin daily urine ovulation tests on Day 11 of their first cycle, and will record the results with the Clue app. During the second month of cycle monitoring, the MRI will be scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they will use the estradiol patch before getting the MRI. They will apply the placebo patch during the third cycle.
Group III: Cohort 1: PTSD Receiving Placebo then EstradiolExperimental Treatment2 Interventions
Participants with PTSD will record their first cycle with the Clue app. They will receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Group IV: Cohort 1: PTSD Receiving Estradiol then PlaceboExperimental Treatment2 Interventions
Participants with PTSD will record their first cycle with the Clue app. They will receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Group V: Cohort 2: Trauma Control Receiving Estradiol, then PlaceboActive Control2 Interventions
Participants with trauma exposure will begin daily urine ovulation tests on Day 11 of their first cycle, and will record the results with the Clue app. During the second month of cycle monitoring, the MRI will be scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they will use the estradiol patch before getting the MRI. They will apply the placebo patch during the third cycle.
Group VI: Cohort 2: Healthy Control Receiving Estradiol then PlaceboActive Control2 Interventions
Participants without trauma history or psychiatric disorder will begin daily urine ovulation tests on Day 11 of their first cycle, and will record the results with the Clue app. During the second month of cycle monitoring, the MRI will be scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they will use the estradiol patch before getting the MRI. They will apply the placebo patch during the third cycle.
Group VII: Cohort 2: Trauma Control Receiving Placebo then EstradiolActive Control2 Interventions
Participants with trauma exposure will begin daily urine ovulation tests on Day 11 of their first cycle, and will record the results with the Clue app. During the second month of cycle monitoring, the MRI will be scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they will use the placebo patch before getting the MRI. They will apply the estradiol patch during the third cycle.
Group VIII: Cohort 1: Healthy Controls Receiving Placebo then EstradiolActive Control2 Interventions
Participants without trauma history or psychiatric disorder will will record their first cycle with the Clue app. They will receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Group IX: Cohort 2: Healthy Control Receiving Placebo then EstradiolActive Control2 Interventions
Participants without trauma history or psychiatric disorder will begin daily urine ovulation tests on Day 11 of their first cycle, and will record the results with the Clue app. During the second month of cycle monitoring, the MRI will be scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they will use the placebo patch before getting the MRI. They will apply the estradiol patch during the third cycle.
Group X: Cohort 1: Trauma without PTSD Receiving Estradiol then PlaceboActive Control2 Interventions
Participants with trauma exposure will record their first cycle with the Clue app. They will receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Group XI: Cohort 1: Trauma without PTSD Receiving Placebo then EstradiolActive Control2 Interventions
Participants with trauma exposure will record their first cycle with the Clue app. They will receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Group XII: Cohort 1: Healthy Controls Receiving Estradiol then PlaceboActive Control2 Interventions
Participants without trauma history or psychiatric disorder will record their first cycle with the Clue app. They will receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol patch
2019
Completed Phase 1
~530

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,459 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,456 Total Patients Enrolled
Jennifer Stevens, PhDPrincipal Investigator - Emory University
Medical School - Emory University, Doctor of Medicine
Oregon Health & Science University, Residency in Ophthalmology

Media Library

Estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03973229 — Phase < 1
Post-Traumatic Stress Disorder Research Study Groups: Cohort 2: Trauma Control Receiving Estradiol, then Placebo, Cohort 2: PTSD Receiving Placebo then Estradiol, Cohort 2: Healthy Control Receiving Estradiol then Placebo, Cohort 2: PTSD Receiving Estradiol then Placebo, Cohort 2: Trauma Control Receiving Placebo then Estradiol, Cohort 1: Healthy Controls Receiving Placebo then Estradiol, Cohort 2: Healthy Control Receiving Placebo then Estradiol, Cohort 1: PTSD Receiving Estradiol then Placebo, Cohort 1: PTSD Receiving Placebo then Estradiol, Cohort 1: Trauma without PTSD Receiving Estradiol then Placebo, Cohort 1: Trauma without PTSD Receiving Placebo then Estradiol, Cohort 1: Healthy Controls Receiving Estradiol then Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT03973229 — Phase < 1
Estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03973229 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this investigation still open?

"Affirmative. Clinicaltrials.gov attests to the current recruitment status of this trial, which was initially posted on November 11th 2019 and recently updated February 17th 2022. The study requires 240 participants sourced from a single site."

Answered by AI

How many individuals are currently being monitored as part of this research endeavor?

"Affirmative. Information available on clinicaltrials.gov implies that this medical research is actively seeking participants, having been initially posted on November 11th 2019 and most recently updated February 17th 2022. The trial requires the enrolment of 240 patients from 1 site."

Answered by AI

Does this research encompass participants who are of advanced age?

"This trial is only open to patients aged 18-35, while those younger and older have their own clinical trials; 51 for the former and 307 for the latter."

Answered by AI

To what end is Estradiol patch typically utilized?

"A lack of menstruation for the prior 6 months, a deficiency in estrogen levels, and associated menopausal symptoms can be managed through Estradiol patch therapy."

Answered by AI

Who would qualify for inclusion in this research endeavor?

"This medical trial is recruiting 240 volunteers between the ages of 18 and 35, all of whom currently suffer from post traumatic stress disorder (PTSD). In addition to these criteria, participants must also be African American women with access to a smartphone who are willing to install the Clue application."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Georgia
How old are they?
18 - 65
What site did they apply to?
Grady Memorial Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Neuroendocrine Risk for PTSD in Women
Jennifer Stevens 2019. "Neuroendocrine Risk for PTSD in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03973229.
All > Ptsd
~13 spots leftby Aug 2024
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