Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 7:11 AM
Study NCT ID:
NCT00472004
Status:
COMPLETED
Last Update Posted:
2010-10-29
First Post:
2007-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C027385', 'term': 'tibolone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-28', 'studyFirstSubmitDate': '2007-05-08', 'studyFirstSubmitQcDate': '2007-05-08', 'lastUpdatePostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased of Vasomotor Symptoms [from baseline to six and twelve months]', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in Body Weight (from baseline to six and twelve months)', 'timeFrame': '1 year'}, {'measure': 'Quality of Life (from baseline to six and twelve months)', 'timeFrame': '1 year'}, {'measure': 'Treatment Adherence (from baseline to six and twelve months)', 'timeFrame': '1 year'}, {'measure': 'Breast Tenderness (from baseline to six and twelve months)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vasomotor Symptoms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0753T-101800&StudyName=Study%20Comparing%2017B%20Estradiol/TMG%20CC%201mg%20Vs.%20Tibolone%20In%20Postmenopausal%20Women', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy postmenopausal women\n* Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period\n* At least 1 year of natural occurring amenorrhea\n\nExclusion Criteria:\n\n* Known or suspected estrogen-dependent neoplasia\n* Endometrial hyperplasia\n* Any malignancy with the exception of a history of basal cell carcinoma of the skin'}, 'identificationModule': {'nctId': 'NCT00472004', 'briefTitle': 'Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.', 'orgStudyIdInfo': {'id': '0753T-101800'}, 'secondaryIdInfos': [{'id': 'B2481004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration', 'interventionNames': ['Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Tibolone 2.5 mg 1 daily, 1 year duration', 'interventionNames': ['Drug: Tibolone (Livial)']}], 'interventions': [{'name': '17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)', 'type': 'DRUG', 'otherNames': ['Totelle'], 'description': '17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration', 'armGroupLabels': ['1']}, {'name': 'Tibolone (Livial)', 'type': 'DRUG', 'otherNames': ['Livial'], 'description': 'Tibolone 2.5 mg 1 daily, 1 year duration', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01090', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc'}}}}