Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-26 @ 6:00 PM
Study NCT ID:
NCT07160504
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endogenous thrombin potential (ETP)', 'timeFrame': '0 months, 3 months', 'description': 'nmol/l x min'}, {'measure': 'Endogenous trombin lag time (LT)', 'timeFrame': '0 months, 3 months', 'description': 'min'}, {'measure': 'Endogenous trombin peak height', 'timeFrame': '0 months, 3 months', 'description': 'nmol/l'}, {'measure': 'Factor VIII (FVIII)', 'timeFrame': '0 months, 3 months', 'description': 'Percentage'}, {'measure': 'Antithrombin', 'timeFrame': '0 months, 3 months', 'description': 'Percentage'}, {'measure': 'Protein S', 'timeFrame': '0 months, 3 months', 'description': 'Percentage'}, {'measure': 'Protein C', 'timeFrame': '0 months, 3 months', 'description': 'Percentage'}, {'measure': 'D-dimer', 'timeFrame': '0 months, 3 months', 'description': 'ng/mL'}, {'measure': 'CRP', 'timeFrame': '0 months, 3 months', 'description': 'mg/l'}, {'measure': 'Fibrinogen', 'timeFrame': '0 months, 3 months', 'description': 'g/l'}, {'measure': 'Tissue-type plaminogen activator (t-PA)', 'timeFrame': '0 months, 3 months', 'description': 'ng/mL'}, {'measure': 'Plasminogen activator inhibitor type 1 (PAI-1)', 'timeFrame': '0 months, 3 months', 'description': 'ng/mL'}, {'measure': 'Faktor XII (FXII)', 'timeFrame': '0 months, 3 months', 'description': 'μg/mL'}, {'measure': 'Prekallikrein (PK)', 'timeFrame': '0 months, 3 months', 'description': 'μg/mL'}, {'measure': 'H-Kininogen (HK)', 'timeFrame': '0 months, 3 months', 'description': 'Percentage'}, {'measure': 'Cleaved H-Kininogen (cHK)', 'timeFrame': '0 months, 3 months', 'description': 'μg/mL'}, {'measure': 'C1-esterase inhibitor (C1-inh)', 'timeFrame': '0 months, 3 months', 'description': 'g/L'}, {'measure': 'Endogenous kallikrein potential (EKP)', 'timeFrame': '0 months, 3 months', 'description': 'nmol/L x min'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postmenopausal', 'Hemostasis', 'Venous thromboembolic event'], 'conditions': ['Vagina Atrophy']}, 'descriptionModule': {'briefSummary': 'This study investigates whether vaginal estrogen treatment has an effect on hemostatic parameters in postmenopausal women. Blood samples are collected before and after 3 months treatment to assess changes in hemostasis.', 'detailedDescription': 'This prospective cohort study includes 90 postmenopausal women aged ≥ 50, having vaginal atrophy symptoms and indication for treatment with vaginal estrogen tablets 10 µg at least 3 times a week for 3 months. Participants are divided into 2 study populations. Study population 1: 45 without a history of venous thromboembolic event and study population 2: 45 with a history of venous thromboembolic event.\n\nParticipation will involve 2 visits:\n\n* First visit: prior the initiation of treatment an interview is carried out to assess inclusion criteria and information on demographics followed by blood sampling.\n* Second visit: follow-up blood sampling after three months treatment. Hemostatic parameters will be assessed, comparing the blood samples at baseline with the follow-up blood sample.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women aged ≥ 50\n* Symptomatic vaginal atrophy\n* Indication for standard treatment with vaginal estrogen tablets 10 µg at least three times a week\n* Study population 1: without a history of venous thromboembolic event\n* Study population 2: with a history of venous thromboembolic event\n\nExclusion Criteria:\n\n* Unable to give written informed consent\n* Does not speak Danish\n* Current cancer treatment\n* Current treatment with blood thinning medication (except plateletinhibitor)\n* Current treatment with local or systematic estrogen\n* Systemic inflammatory disease, liver disease or kidney disease'}, 'identificationModule': {'nctId': 'NCT07160504', 'briefTitle': 'Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?', 'orgStudyIdInfo': {'id': '2024-519539-41-00'}, 'secondaryIdInfos': [{'id': '2024-519539-41-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vaginal estrogen treatment', 'interventionNames': ['Drug: Vaginal estradiol tablets']}], 'interventions': [{'name': 'Vaginal estradiol tablets', 'type': 'DRUG', 'description': 'Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).', 'armGroupLabels': ['Vaginal estrogen treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Pinar Bor, MD, PhD, Prof.', 'role': 'CONTACT', 'email': 'isipinbo@rm.dk', 'phone': '22504767'}], 'facility': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Pinar Bor, Pinar Bor, MD, PhD, Prof.', 'role': 'CONTACT', 'email': 'isipinbo@rm.dk', 'phone': '+45 78 42 11 13'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}