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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
Must not have
History of embolism
Women currently taking any form of hormone-based birth control or other hormonal supplement
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

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
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I have a smartphone and am willing to install the Clue app.
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I am an African American woman.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a blood clot in the past.
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I am currently using hormone-based birth control or taking hormonal supplements.
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I am currently experiencing symptoms of psychosis or bipolar disorder.
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I weigh less than or equal to 250lbs and do not have metal implants.
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I have a condition that causes my blood to clot more than normal.
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I am not pregnant or breastfeeding.
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I am currently taking medication for my mental health.

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 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 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 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 VIII: 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 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
2,820 Previous Clinical Trials
2,692,579 Total Patients Enrolled
Emory UniversityLead Sponsor
1,655 Previous Clinical Trials
2,572,243 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 1: Healthy Controls Receiving Placebo then Estradiol, Cohort 2: Healthy Control Receiving Estradiol then Placebo, Cohort 2: PTSD Receiving Estradiol then Placebo, Cohort 2: PTSD Receiving Placebo then Estradiol, Cohort 2: Trauma Control Receiving Estradiol, then Placebo, Cohort 2: Trauma Control 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
~0 spots leftby Aug 2024