NCT07419594

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Aug 2024Feb 2028

Study Start

First participant enrolled

August 19, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

February 19, 2026

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

PTSDIntrusive MemoriesIntrusion SymptomTraumaIntrusion

Keywords

Trauma filmEstradiolptsdintrusive memoriesintrusionestrogen

Outcome Measures

Primary Outcomes (1)

  • 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

    four consecutive days

Secondary Outcomes (4)

  • Noradrenergic System (measured with salivary alpha-amylase - u/ml)

    Day 1

  • Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)

    Day 1

  • Estradiol and Progesterone

    Day 1

  • heart rate variability

    Day 1

Study Arms (3)

Estradiol before the trauma paradigme

EXPERIMENTAL

3mg of oral estradiol valerate administered two hours before the trauma film (during acquisition of trauma associated memories)

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)

Drug: Estradiol Valerate

Placebo before and after the trauma film paradigm

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Estradiol ValerateDRUG

3mg of Estradiol Valerate pills, administred orally

Estradiol after the trauma paradigmeEstradiol before the trauma paradigme
PlaceboDRUG

Plabo pill

Placebo before and after the trauma film paradigm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants who identify as women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy female volunteers
  • German on B1 level

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Katja Wingenfeld, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Stefan Roepke, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tolou Maslahati, M.Sc.

CONTACT

0049 30 450 517 567tolou.maslahati@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind, randomized, placebo controlled
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

August 19, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 29, 2028

Last Updated

February 19, 2026

Record last verified: 2025-10

Locations

DE(1)