Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:50 PM
Study NCT ID:
NCT07420218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Menopausal Hormones and Sympathetic Activation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004967', 'term': 'Estrogens'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adrenergic Receptor Control of Vascular Function', 'timeFrame': 'on day 6-8 of the hormone treatment', 'description': 'changes in cutaneous vascular conductance during norepinephrine perfusions with and without beta blockade.'}], 'primaryOutcomes': [{'measure': 'sympathetic nerve activity', 'timeFrame': 'on day 6-8 of the hormone treatment', 'description': 'Sympathetic nerve activity will be measured using a technique called microneurography and reported as burst frequency (number of bursts per minute) and burst area (height / size of bursts).'}], 'secondaryOutcomes': [{'measure': 'BOLD fMRI', 'timeFrame': 'on day 6-8 of the hormone treatment', 'description': 'functional connectivity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perimenopausal Women']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand how changes in menopausal hormones like estradiol and follicle-stimulating hormone (FSH) impact sympathetic nervous system function. To do so, the investigators will use a medication to control the production of estradiol and FSH, and in some participants, add-back estradiol to isolate its effects. The investigators will measure sympathetic activation centrally (in the brain using MRI), peripherally in the nervous system, and also examine adrenergic receptor mediated control of vascular function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Perimenopausal (based on changes in menstrual cycle)\n* Ages 40-58 years\n\nExclusion Criteria:\n\n* History of CVD, blood clots, stroke\n* History of Cancer\n* History of Liver or Kidney disease\n* History of Neurological disease\n* Diabetes\n* BMI\\>35kg/m2\n* Pregnant, planning on becoming pregnant, or breast feeding\n* Allergy to Latex\n* Use of Tobacco\n* Hysterectomy\n* Blood pressure \\>140/90 mmHg\n* Current or prior use of hormone replacement therapy (within 3 mo)'}, 'identificationModule': {'nctId': 'NCT07420218', 'briefTitle': 'Menopausal Hormones and Sympathetic Activation', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women', 'orgStudyIdInfo': {'id': '2395015'}, 'secondaryIdInfos': [{'id': 'R01AG092632', 'link': 'https://reporter.nih.gov/quickSearch/R01AG092632', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estrogen', 'interventionNames': ['Drug: Estrogen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Estrogen', 'type': 'DRUG', 'description': 'Estradiol patch (0.1mg) All women will use a GnRH antagonist for 8 days. Some women will receive an estradiol patch for to wear on days 3-8, whereas other women will receive a placebo patch to wear on days 3-8. Measurements of sympathetic activation will occur on days 6-8.', 'armGroupLabels': ['Estrogen']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'All women will use a GnRH antagonist for 8 days. Some women will receive an estradiol patch for to wear on days 3-8, whereas other women will receive a placebo patch to wear on days 3-8. Measurements of sympathetic activation will occur on days 6-8.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Megan Wenner, PhD', 'role': 'CONTACT', 'email': 'mwenner@udel.edu', 'phone': '13028317343'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}