PTSDEstraMemoNCT07419594
Estradiol and Intrusive Memories
A study testing Estradiol Valerate in people with PTSD and Intrusive Memories, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the current project is to investigate the impact of 3mg of oral estradiol valerate on the formation of intrusive memories after analog trauma. A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD, Intrusive Memories, Intrusion Symptom
- What is being tested?
- Estradiol Valerate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2024to 29 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy female volunteers
- German on B1 level
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 12203
Tolou Maslahati, M.Sc., +49 30 450 517567, tolou.maslahati@charite.de
About this study
Official title: The Effect of Estradiol on the Acquisition and Consolidation of Trauma-Associated Memories
The aim of the current project is to investigate the impact of 3mg of oral estradiol valerate on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of oral estradiol on intrusive symptoms during and immediately after exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral estradiol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
- Conditions
- PTSD, Intrusive Memories, Intrusion Symptom, Trauma, Intrusion
- Being tested
- Estradiol Valerate, Placebo
- Keywords
- Trauma film, Estradiol, ptsd, intrusive memories, intrusion, estrogen
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol ValerateDrug
3mg of Estradiol Valerate pills, administred orally
PlaceboDrug
Plabo pill
| Study group | Role | What they receive |
|---|---|---|
| Estradiol before the trauma paradigme | Experimental | 3mg of oral estradiol valerate administered two hours before the trauma film (during acquisition of trauma associated memories) Receives: Drug: Estradiol Valerate |
| Estradiol after the trauma paradigme | Experimental | 3mg of oral estradiol valerate administered immediately after the trauma film (during consolidation of trauma associated memories) Receives: Drug: Estradiol Valerate |
| Placebo before and after the trauma film paradigm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Intrusive Memories in the following four days after the intervention
Influence of estradiol on the development of intrusive memories measured with an intrusion diary
Measured: four consecutive days
Secondary outcomes (4)
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Influence of noradrenergic system measured with salivary alpha-amylase on the development of intrusive memories
Measured: Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Influence of HPA-axis measured with salivary cortisol on the development of intrusive memories
Measured: Day 1
Estradiol and Progesterone
Influence of salivary endogenous estradiol and progesterone on the development of intrusive memories.
Measured: Day 1
heart rate variability
Influence of heart rate variability on the development of intrusive memories
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start19 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Roepke, Charite University, Berlin, Germany
- Investigators
- Katja Wingenfeld, Prof. Dr., Principal investigator, Charite University, Berlin, GermanyStefan Roepke, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419594
- Sponsor's protocol ID
- EstraMe
- Acronym
- EstraMemo
- Status last verified
- Oct 2025
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided