Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-01 @ 11:11 AM
Study NCT ID:
NCT06787066
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D010646', 'term': 'Phentolamine'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sympathetic transduction', 'timeFrame': '1 day (single study visit)', 'description': 'Assessing the relative change in blood flow (Doppler ultrasound) following an increase in sympathetic nerve activity.'}], 'secondaryOutcomes': [{'measure': 'Blood flow', 'timeFrame': '1 day (single study visit)', 'description': 'Measuring femoral artery blood flow using Doppler ultrasound.'}, {'measure': 'Muscle sympathetic nerve activity', 'timeFrame': '1 day (single study visit)', 'description': 'Measuring the sympathetic nerve activity of the fibular nerve using a microelectrode .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menopause', 'Sympathetic nerve activity', 'Sympathetic transduction', 'Blood flow', 'Women's health', 'Blood pressure'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'The investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Assigned female at birth\n* 18-70 years of age\n* Body mass index (BMI) \\<30 kg/m2\n\nExclusion Criteria:\n\n* Assigned male at birth\n* Pregnancy, breastfeeding\n* Body mass index ≥30 kg/m2\n* Oral hormonal contraception in last 6 months, history of hormone replacement therapy, oophorectomy\n* Current smoking/nicotine use\n* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy\n* Nerve/neurologic disease\n* Cardiovascular, hepatic, renal, respiratory disease\n* Blood pressure ≥140/90 mmHg\n* Diabetes, Polycystic ovarian syndrome\n* Communication barriers\n* Prescription medications'}, 'identificationModule': {'nctId': 'NCT06787066', 'briefTitle': 'Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms', 'orgStudyIdInfo': {'id': '2125473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Women', 'description': 'Women ages 18-70 years will participate.', 'interventionNames': ['Drug: Propranolol Hydrochloride', 'Drug: Phentolamine Injection']}], 'interventions': [{'name': 'Propranolol Hydrochloride', 'type': 'DRUG', 'description': 'Examine how IV propranolol impacts sympathetic transduction', 'armGroupLabels': ['Women']}, {'name': 'Phentolamine Injection', 'type': 'DRUG', 'description': 'Examine how IV phentolamine impacts sympathetic transduction', 'armGroupLabels': ['Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacqueline Limberg', 'role': 'CONTACT', 'email': 'limbergj@missouri.edu', 'phone': '573-882-2544'}], 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'Jacqueline Limberg, PhD', 'role': 'CONTACT', 'email': 'limbergj@missouri.edu', 'phone': '573-882-2420'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jacqueline K Limberg, PhD', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}