Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-02 @ 8:04 AM
Study NCT ID:
NCT00185328
Status:
COMPLETED
Last Update Posted:
2008-12-12
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Angeliq in Thai Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Thailand']}, 'interventionBrowseModule': {'meshes': [{'id': 'C488382', 'term': 'estradiol-drospirenone combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-11', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2008-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relative change in the frequency of hot flushes', 'timeFrame': 'At baseline, week 4, 8, 12'}], 'secondaryOutcomes': [{'measure': 'The change in intensity of hot flushes', 'timeFrame': 'At baseline, week 4, 8, 12'}, {'measure': 'The relative change in frequency of hot flushes', 'timeFrame': 'At baseline, week 4, 8'}, {'measure': 'The change in intensity of hot flushes', 'timeFrame': 'At baseline, week 4, 8'}, {'measure': 'The proportions of subjects with urogenital symptoms', 'timeFrame': 'At baseline, week 4, 8, 12'}, {'measure': 'Bleeding pattern', 'timeFrame': 'At baseline, week 4, 8, 12'}, {'measure': 'Adverse events collection', 'timeFrame': 'Collection of AE throughout the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postmenopause'], 'conditions': ['Postmenopause']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.\n\nBayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women with hot flushes\n\nExclusion Criteria:\n\n* Women with a contraindication for Hormone Replacement Therapy (HRT)'}, 'identificationModule': {'nctId': 'NCT00185328', 'briefTitle': 'Efficacy and Tolerability of Angeliq in Thai Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles', 'orgStudyIdInfo': {'id': '91436'}, 'secondaryIdInfos': [{'id': '309367'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Estradiol/DRSP (Angeliq, BAY86-4891)']}], 'interventions': [{'name': 'Estradiol/DRSP (Angeliq, BAY86-4891)', 'type': 'DRUG', 'description': '1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Therapeutic Area Head', 'oldOrganization': 'Bayer Schering Pharma AG'}}}}