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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 13 -15 (1, 3, and 6 months follow up)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman aged between 18 and 45.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline on extinction-induced functional MRI responses.
Secondary outcome measures
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 • NCT0225517518%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed
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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,518 Total Patients Enrolled
Mohammed R Milad, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a mental disorder that causes hallucinations or delusions, which could make it difficult to focus on posttraumatic stress disorder (PTSD) during the study.I am a woman aged between 18 and 45.I am using specific types of birth control pills, the NuvaRing, or a birth control patch.I have had PTSD symptoms for over a month.I have a history of brain disease, seizures, or major head injury.I have been diagnosed with bipolar I disorder and had a manic episode in the past year.I am currently taking benzodiazepines.I am currently undergoing therapy for trauma.I have had breast cancer or a cancer that responds to hormone therapy.My medications have been the same for the last 3 months, except for any benzodiazepines I might be taking.You have thoughts of hurting yourself and require immediate help from a specialized care team.You have experienced a traumatic event.You engage in behaviors that harm yourself, such as trying to hurt yourself or thinking about ending your life, and need medical help for it or experience it on a daily basis.
Research Study Groups:
This trial has the following groups:- Group 1: Prolonged Exposure (PE) therapy with estradiol
- Group 2: Prolonged Exposure (PE) therapy with placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can currently enrolled patients discontinue their participation in the trial at any time?
"This trial, which was initially posted on June 24th 2020 according to clinicaltrials.gov, is still looking for participants. The most recent update was on June 2nd 2022."
Answered by AI
For this research, are elderly patients ineligible?
"This trial focuses on a young demographic, only enrolling patients between 18-45 years old. By comparison, there are 42 similar studies for minors and 270 for adults over the age of 65."
Answered by AI
What is the Estradiol risk profile for patients?
"Estradiol is classified as a level 3 medication on Power's safety scale. This means that while there is still some testing to be done in phase 3 trials, the drug has shown efficacy and multiple rounds of data support its safety."
Answered by AI
How many people are being signed up for this experiment?
"That is correct. The listing on clinicaltrials.gov says that the research team is still looking for enrollees and 80 people are needed in total. This project was first announced on June 24th, 2020 with the most recent update being published on June 2nd, 2022. There will be just 1 study location."
Answered by AI
Are there specific prerequisites to enrolling in this clinical trial?
"As this is a clinical trial for PTSD sufferers, only patients that have been diagnosed with PTSD and are between 18-45 years old can be accepted. A total of 80 people will be participating in the trial."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania Perelman School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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