Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-04-25 @ 8:25 PM
Study NCT ID:
NCT01703520
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 575216}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2012-10-08', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year', 'timeFrame': 'Up to 14 years'}, {'measure': 'Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride', 'timeFrame': 'Up to 14 years'}, {'measure': 'Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride', 'timeFrame': 'Up to 14 years'}, {'measure': 'Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls', 'timeFrame': 'Up to 19 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Males breast cancer', 'Finasteride', 'PROSCAR®', 'PROPECIA®'], 'conditions': ['Male Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29239131', 'type': 'RESULT', 'citation': 'Meijer M, Thygesen LC, Green A, Emneus M, Brasso K, Iversen P, Pukkala E, Bolin K, Stavem K, Ersboll AK. Finasteride treatment and male breast cancer: a register-based cohort study in four Nordic countries. Cancer Med. 2018 Jan;7(1):254-260. doi: 10.1002/cam4.1273. Epub 2017 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant's study medical information available in population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, or Sweden within the observation period of 1995 to 2013\n* Male with breast cancer with medical information in one of the 4 country-specific registries in this study OR country- and age-matched control men without breast cancer and with medical information in one of the 4 country-specific registries\n* Study participant's exposure to finasteride is available\n\nExclusion Criteria:\n\nFor country- and age-matched control men without breast cancer\n\n* Previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer\n* Previous prostatectomy\n* Finasteride or dutasteride use (dutasteride is a drug in the same class as finasteride) within first 6 months of registration in the prescription registers (new user design)."}, 'identificationModule': {'nctId': 'NCT01703520', 'briefTitle': 'Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden', 'orgStudyIdInfo': {'id': '0906-162'}, 'secondaryIdInfos': [{'id': '2003.021', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male Finasteride Users', 'description': 'Male finasteride users aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).'}, {'label': 'Male Finasteride Non-users', 'description': 'Country-matched male finasteride non-users aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).'}, {'label': 'Men with Breast Cancer', 'description': 'Breast cancer cases among men aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).'}, {'label': 'Men without Breast Cancer', 'description': 'Country- and age-matched controls: men without breast cancer aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institute for Applied Economics and Health Research Aps', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}