Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-29 @ 7:18 PM
Study NCT ID:
NCT01679795
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2012-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C027385', 'term': 'tibolone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2012-09-03', 'studyFirstSubmitQcDate': '2012-09-05', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery', 'timeFrame': '30 days', 'description': 'Flow-mediated dilation will be measured by high resolution ultrasound'}]}, 'conditionsModule': {'keywords': ['hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone'], 'conditions': ['Flow-mediated Dilation Evaluation of the Brachial Artery']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women without menstrual cycles whithin the last 12 months and FSH\\>30IU/L\n* Healthy women\n* Women that were not using drugs with potential vascular effect whithin the last 1 year\n* Women that never used hormone replacement therapy\n\nExclusion Criteria:\n\n* Smoking\n* Blood Pressure \\> 160/90 mm Hg.\n* Breast and or endometrial cancer\n* History of acute myocardial infarction\n* Diabetes\n* Vaginal bleeding of any origin\n* Hepatic disease\n* thrombophlebitis or thromboembolic disorders'}, 'identificationModule': {'nctId': 'NCT01679795', 'briefTitle': 'Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'orgStudyIdInfo': {'id': 'TDILA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tibolone', 'description': 'patientes will use tibolone 2,5mg/day during 30 days', 'interventionNames': ['Drug: Tibolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo use', 'description': 'Patients will use placebo for 30 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tibolone', 'type': 'DRUG', 'otherNames': ['Livial'], 'armGroupLabels': ['Tibolone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'hospital das Clinicas - Universidade Federal de Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Selmo Geber', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}