Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-27 @ 12:31 PM
Study NCT ID:
NCT00809068
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2008-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'C027385', 'term': 'tibolone'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-31', 'studyFirstSubmitDate': '2008-06-10', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL subpopulation analysis', 'timeFrame': 'August 2009'}], 'secondaryOutcomes': [{'measure': 'Increase in HDL subpopulations', 'timeFrame': 'December 2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Menopause', 'menopausal symptoms', 'tibolone', 'HDL-C', 'fenofibrate'], 'conditions': ['HDL Cholesterol']}, 'descriptionModule': {'briefSummary': 'Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.\n\nThis study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.', 'detailedDescription': 'Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL, consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on cellular cholesterol efflux.\n\nPPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the expression and hepatic secretion of HDL apoAI and apoAII.\n\nWe hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by tibolone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women\n* More than 6 months of amenorrhoea\n* Raised FSH and low oestradiol level\n* If hysterectomised, raised FSH and low oestradiol level\n\nExclusion Criteria:\n\n* Diabetes\n* Renal failure\n* Proteinuria\n* High alcohol intake\n* Regular endurance exercise\n* Active weight loss of dieting\n* Smokers\n* Agents known to influence lipid metabolism\n* Major systemic illness\n* Intolerance to tibolone and fenofibrate\n* Cholelithiasis\n* CK and ALT \\> 2ULN\n* Bleeding disorders\n* Peptic ulcer disease.'}, 'identificationModule': {'nctId': 'NCT00809068', 'acronym': 'TibFen', 'briefTitle': 'High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone', 'organization': {'class': 'OTHER', 'fullName': 'Keogh Institute for Medical Research'}, 'officialTitle': 'Effects of Tibolone and PPARĪ±-agonist on HDL Metabolism in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'ID: 2005-001'}, 'secondaryIdInfos': [{'id': 'SCGH Research Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'fenofibrate and tibolone', 'interventionNames': ['Drug: fenofibrate and tibolone']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'tibolone', 'interventionNames': ['Drug: tibolone']}], 'interventions': [{'name': 'fenofibrate and tibolone', 'type': 'DRUG', 'otherNames': ['Lipidil', 'Livial'], 'description': 'fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks', 'armGroupLabels': ['1']}, {'name': 'tibolone', 'type': 'DRUG', 'otherNames': ['Livial'], 'description': 'tibolone 2.5 mg daily 23 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': "Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands", 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Bronwyn G Stuckey, MBBS FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keogh Institute for Medical Research'}, {'name': 'Gerald F Watts, MD PhD FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School pf Medicine and Pharmacology, Royal Perth Hospital.'}, {'name': 'Rosalind Hampton, BSc MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keogh Institute for Medical Research'}, {'name': 'Hugh Barrett, BAgSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine and Pharmacology, Royal Perth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keogh Institute for Medical Research', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Clinical Professor Bronwyn Stuckey', 'oldOrganization': 'Keogh Institute for Medical Research'}}}}