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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)

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ mid-cycle second cycle, mid-cycle third cycle (each cycle is an average of 28 days)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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%

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

0 / 9Eligibility criteria met