Menu
Recruiting NCT07419594

Estradiol and Intrusive Memories

No phase Interventional PTSD Intrusive Memories Intrusion Symptom Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Estradiol Valerate, Placebo.
Who it may be relevant to
Registry conditions: PTSD, Intrusive Memories, Intrusion Symptom, Trauma. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Estradiol on the Acquisition and Consolidation of Trauma-Associated Memories

Overview

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.

Interventions

  • Drug Estradiol Valerate
    3mg of Estradiol Valerate pills, administred orally
  • Drug Placebo
    Plabo pill

Primary outcome measures

  • Change of Intrusive Memories in the following four days after the intervention [Time frame: four consecutive days]
Secondary outcome measures (4)
  • Noradrenergic System (measured with salivary alpha-amylase - u/ml) [Time frame: Day 1]
  • Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) [Time frame: Day 1]
  • Estradiol and Progesterone [Time frame: Day 1]
  • heart rate variability [Time frame: Day 1]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Germany · 1 center
  • Charité - Universitätsmedizin Berlin — Berlin

Identifiers

NCT: NCT07419594 · EstraMe

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗