Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT00335218
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2006-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fat Distribution in Healthy Early Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C454300', 'term': 'estradiol valerate-dienogest'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2006-02-24', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual relative change of abdominal visceral fat measured by magnetic resonance imaging', 'timeFrame': 'Baseline and after 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Parameters of body composition and lipid metabolism', 'timeFrame': 'Baseline and after 24 weeks of treatment'}, {'measure': 'Adverse events collection', 'timeFrame': 'During whole study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early postmenopausal state', 'Climacteric symptoms', 'Hormone replacement therapy'], 'conditions': ['Healthy', 'Postmenopause']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '48 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy early postmenopausal women\n* BMI between 25 and 30\n\nExclusion Criteria:\n\n* Contra-indication(s) for hormone treatment\n* Metabolic diseases\n* Concomitant medication with influence on lipid metabolism'}, 'identificationModule': {'nctId': 'NCT00335218', 'briefTitle': 'Fat Distribution in Healthy Early Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women', 'orgStudyIdInfo': {'id': '91161'}, 'secondaryIdInfos': [{'id': '306387'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Climodien / Lafamme (BAY86-5027)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Climodien / Lafamme (BAY86-5027)', 'type': 'DRUG', 'description': '1 tablet daily (2 mg EV + 2 mg DNG)', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet daily', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1060', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1200', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}