Estrogen and Fear in PTSD

Completed · Phase 3 · Has a placebo group

Conditions studied: PTSD

In brief

The purpose of this research study is to determine if taking a pill of estradiol (E2) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). 80 subjects will take part in this research study across UTHealth Houston and UPenn (40 subjects at each site). Participants will be randomized into one of two groups, PE + E2 or PE + placebo. The study will include preliminary screening and baseline visits, experimental visits, and therapy visits over the course of six weeks. Several follow-up visits will take place.

Key facts

Study ID: NCT04192266
Run by: The University of Texas Health Science Center, Houston
People needed: 83
Starts: 2020-06-24
Expected to finish: 2024-12-02
Last updated by the study team: 2026-01-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female, 18-45 years of age
Chronic (at least one month post-trauma) DSM-5 FULL PTSD diagnosis OR subPTSD diagnosis (subPTSD defined as: meeting criterion A, F, G, H, and clusters B, C, and at least 1 of the clusters D or E.)
CAPS-5 Past Month score ≥ 20
Criterion A traumatic event
Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines)
Women on oral contraceptives, specifically those using monophasic or biphasic of first, second, third or fourth generation with up to 35mcg of ethinyl estradiol; OR using etonogestrel / ethinyl estradiol 0.120mg/0.015mg per day vaginal ring birth control; OR using the norelgestromin / ethinyl estradiol 0.150mg/0.035mg per day transdermal patch birth control.
Willing and able to provide informed consent

You may not qualify if…

Diagnosis of bipolar I disorder with a past year manic episode
Diagnosis of a psychotic disorder or psychotic symptoms that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment.
Diagnosis of moderate or severe substance use disorder that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment.
Cognitive impairment that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment.
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).
Suicidal ideation with imminent risk that warrants a higher level of care.
Concurrent trauma focused psychotherapy
Pregnancy (to be ruled out by urine ß-HCG).
Metallic implants or devices contraindicating magnetic resonance imaging by interfering with patient safety or fMRI data collection. Cases will be cleared by the Principal Investigator and/or Baylor College of Medicine (Imaging).
History of breast cancer or hormone-responsive cancer.
Use of benzodiazepines
Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily.
High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process, based on investigator/clinician clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)

Where it is running

University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center at Houston (UTHealth Houston) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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