Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT01487304
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020249', 'term': 'Hormone Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3760}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast tenderness'}], 'secondaryOutcomes': [{'measure': 'Patient treatment satisfaction after switch to low dose HRT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Menopause', 'Hormone Replacement Therapy, Post-Menopausal']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Post-menopausal women suffering from climacteric symptoms who could benefit a switch from standard therapy to low dose therapy at the discretion of the individual physician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal'}, 'identificationModule': {'nctId': 'NCT01487304', 'briefTitle': "Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"', 'orgStudyIdInfo': {'id': 'KLIM-1937'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low dose HRT', 'interventionNames': ['Drug: Marketed low dose hormone replacement therapy']}], 'interventions': [{'name': 'Marketed low dose hormone replacement therapy', 'type': 'DRUG', 'description': 'A low dose of marketed HRT products prescribed at the discretion of the treating physician', 'armGroupLabels': ['Low dose HRT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}