Oral estradiol to reduce intrusive memories after trauma film
The Effect of Estradiol on the Acquisition and Consolidation of Trauma-Associated Memories
This trial will test whether a single 3 mg dose of oral estradiol valerate reduces intrusive memories in healthy adult women after viewing a trauma film.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 273 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT07419594 on ClinicalTrials.gov |
What this trial studies
Researchers will use a well-established stress-film paradigm to induce intrusive symptoms in healthy female volunteers. In a double-blind, placebo-controlled design participants receive either 3 mg oral estradiol valerate or placebo around film exposure and record intrusive memories for four days afterwards. Key eligibility rules exclude anyone with current or past DSM-5 psychiatric disorders, physical illnesses, medication use (including oral contraceptives), prior traumatic experiences, pregnancy, lactation, or being in the follicular phase, and participants must speak German at a B1 level. The primary outcome is the number of intrusive memories reported in the four days following the experimental trauma.
Who should consider this trial
Good fit: Ideal candidates are healthy adult women who speak German at a B1 level, are not pregnant or lactating, are medication-free (including no oral contraceptives), have no current or past DSM-5 diagnoses or prior traumatic experiences, and can attend in-person sessions in Berlin.
Not a fit: People with existing PTSD or other psychiatric disorders, a history of trauma, men, those taking oral contraceptives or other medications, pregnant or breastfeeding people, and those unable to attend in-person visits in Berlin are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could point to a simple pharmacological way to reduce early intrusive memories and help prevent PTSD after trauma.
How similar studies have performed: Animal and laboratory studies indicate sex hormones can influence memory consolidation and fear-related memories, but randomized human trials of oral estradiol to prevent intrusive memories after trauma exposure are limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy female volunteers * German on B1 level Exclusion Criteria: * former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) * any physical illnesses * any medication intake (except oral contraceptive) * history of traumatic experience, e.g. history of sexual abuse or rape * pregnancy or lactation period * intake of oral contraceptives * follicular phase of menstrual cycle
Where this trial is running
Berlin, State of Berlin
- Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Katja Wingenfeld, Prof. Dr. — Charite University, Berlin, Germany
- Study coordinator: Tolou Maslahati, M.Sc.
- Email: tolou.maslahati@charite.de
- Phone: 0049 30 450 517 567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.