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Estradiol for Post-Traumatic Stress Disorder

Phase 3

Recruiting

Led By Mohammed R Milad, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female, 18-45 years of age

Be between 18 and 65 years old

Must not have

History of neurological disease (that involves the brain), seizure, or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).

Diagnosis of bipolar I disorder with a past year manic episode

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 13 -15 (1, 3, and 6 months follow up)

Awards & highlights

Pivotal Trial

Summary

This trial is determining whether adding a pill of estradiol to prolonged exposure therapy can improve treatment outcome for women with PTSD.

Who is the study for?

This trial is for women aged 18-45 with PTSD, who have experienced a traumatic event and show chronic symptoms. They must score above a certain threshold on the CAPS-5 scale, be on stable medications (except benzodiazepines), and use specific oral contraceptives or hormonal birth control methods.

What is being tested?

The study tests if estradiol pills can enhance prolonged exposure therapy for PTSD in women. Participants will either receive estradiol or a placebo alongside their therapy sessions over six weeks, with follow-up visits included.

What are the potential side effects?

While not explicitly listed here, potential side effects of estradiol may include nausea, headache, mood changes, breast tenderness, and menstrual changes. Placebos typically have no active ingredients but can cause perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of brain disease, seizures, or major head injury.

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I have been diagnosed with bipolar I disorder and had a manic episode in the past year.

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I have had breast cancer or a cancer that responds to hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 13 -15 (1, 3, and 6 months follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 13 -15 (1, 3, and 6 months follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 13 -15 (1, 3, and 6 months follow up) 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 from Baseline on extinction-induced functional MRI responses.

Secondary study objectives

Change from Baseline on PTSD symptom severity

Changes from Baseline in PTSD symptoms correlations with Bold and SCR changes

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175

18%

Breast Tenderness

15%

Cramps

15%

Itchiness at patch site

12%

Headaches

Nausea

Acne

Lower Back Pain

Hot Flashes

Menstrual Bleeding

Bloating

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Perimenopausal Women, Depressed

Perimenopausal Women, Non-depressed

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Prolonged Exposure (PE) therapy with estradiolExperimental Treatment1 Intervention

A 2.0 mg pill of estradiol (a form of estrogen) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). Prolonged Exposure (PE) therapy is a validated treatment for PTSD. A single dose of estradiol 2mg or placebo will be taken at home by the study participant 5-6 hours before each of 5 PE treatment sessions (sessions 2 to 6)

Group II: Prolonged Exposure (PE) therapy with placeboPlacebo Group1 Intervention

A 2.0 mg placebo pill will be given with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). Prolonged Exposure (PE) therapy is a validated treatment for PTSD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Estradiol

2008

Completed Phase 4

~3960

0 / 4Eligibility criteria met