Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:31 PM
Study NCT ID:
NCT07419594
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estradiol and Intrusive Memories
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double Blind, randomized, placebo controlled'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 273}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Intrusive Memories in the following four days after the intervention', 'timeFrame': 'four consecutive days', 'description': 'Influence of estradiol on the development of intrusive memories measured with an intrusion diary'}], 'secondaryOutcomes': [{'measure': 'Noradrenergic System (measured with salivary alpha-amylase - u/ml)', 'timeFrame': 'Day 1', 'description': 'Influence of noradrenergic system measured with salivary alpha-amylase on the development of intrusive memories'}, {'measure': 'Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)', 'timeFrame': 'Day 1', 'description': 'Influence of HPA-axis measured with salivary cortisol on the development of intrusive memories'}, {'measure': 'Estradiol and Progesterone', 'timeFrame': 'Day 1', 'description': 'Influence of salivary endogenous estradiol and progesterone on the development of intrusive memories.'}, {'measure': 'heart rate variability', 'timeFrame': 'Day 1', 'description': 'Influence of heart rate variability on the development of intrusive memories'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trauma film', 'Estradiol', 'ptsd', 'intrusive memories', 'intrusion', 'estrogen'], 'conditions': ['PTSD', 'Intrusive Memories', 'Intrusion Symptom', 'Trauma', 'Intrusion']}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nThis project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female participants who identify as women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy female volunteers\n* German on B1 level\n\nExclusion Criteria:\n\n* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)\n* any physical illnesses\n* any medication intake (except oral contraceptive)\n* history of traumatic experience, e.g. history of sexual abuse or rape\n* pregnancy or lactation period\n* intake of oral contraceptives\n* follicular phase of menstrual cycle'}, 'identificationModule': {'nctId': 'NCT07419594', 'acronym': 'EstraMemo', 'briefTitle': 'Estradiol and Intrusive Memories', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'The Effect of Estradiol on the Acquisition and Consolidation of Trauma-Associated Memories', 'orgStudyIdInfo': {'id': 'EstraMe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol before the trauma paradigme', 'description': '3mg of oral estradiol valerate administered two hours before the trauma film (during acquisition of trauma associated memories)', 'interventionNames': ['Drug: Estradiol Valerate']}, {'type': 'EXPERIMENTAL', 'label': 'Estradiol after the trauma paradigme', 'description': '3mg of oral estradiol valerate administered immediately after the trauma film (during consolidation of trauma associated memories)', 'interventionNames': ['Drug: Estradiol Valerate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo before and after the trauma film paradigm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Estradiol Valerate', 'type': 'DRUG', 'description': '3mg of Estradiol Valerate pills, administred orally', 'armGroupLabels': ['Estradiol after the trauma paradigme', 'Estradiol before the trauma paradigme']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Plabo pill', 'armGroupLabels': ['Placebo before and after the trauma film paradigm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tolou Maslahati, M.Sc.', 'role': 'CONTACT', 'email': 'tolou.maslahati@charite.de', 'phone': '+49 30 450 517567'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Tolou Maslahati, M.Sc.', 'role': 'CONTACT', 'email': 'tolou.maslahati@charite.de', 'phone': '0049 30 450 517 567'}], 'overallOfficials': [{'name': 'Katja Wingenfeld, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}, {'name': 'Stefan Roepke, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Stefan Roepke', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}