Estrogen plus talk therapy shows promise for PTSD in women
NCT ID NCT04192266
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether taking estrogen pills along with a type of talk therapy called prolonged exposure (PE) can improve PTSD symptoms in women. 83 women aged 18-45 with PTSD took part. They were randomly assigned to receive either estrogen or a placebo pill with their therapy sessions over six weeks. The goal was to see if estrogen helps the brain respond better to therapy and reduces PTSD symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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83 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female, 18-45 years of age 2. 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.) 3. CAPS-5 Past Month score ≥ 20 4. Criterion A traumatic event 5. Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines) 6. 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. 7. Willing and able to provide informed consent Exclusion Criteria: 1. Diagnosis of bipolar I disorder with a past year manic episode 2. 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. 3. 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. 4. Cognitive impairment that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment. 5. 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). 6. Suicidal ideation with imminent risk that warrants a higher level of care. 7. Concurrent trauma focused psychotherapy 8. Pregnancy (to be ruled out by urine ß-HCG). 9. 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). 10. History of breast cancer or hormone-responsive cancer. 11. Use of benzodiazepines 12. Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily. 13. 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas, 77054, United States
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University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
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