<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01703520</url>
  </required_header>
  <id_info>
    <org_study_id>0906-162</org_study_id>
    <secondary_id>2003.021</secondary_id>
    <nct_id>NCT01703520</nct_id>
  </id_info>
  <brief_title>Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).</brief_title>
  <official_title>Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organon and Co</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute for Applied Economics and Health Research Aps</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Organon and Co</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the potential association between finasteride&#xD;
      (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden,&#xD;
      Finland, and Norway from data in national registries. The primary hypothesis of this study is&#xD;
      that the previously reported increased incidence of male breast cancer among finasteride&#xD;
      users is explained by confounding factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2011</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year</measure>
    <time_frame>Up to 14 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride</measure>
    <time_frame>Up to 14 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride</measure>
    <time_frame>Up to 14 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls</measure>
    <time_frame>Up to 19 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">575216</enrollment>
  <condition>Male Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Male Finasteride Users</arm_group_label>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Male Finasteride Non-users</arm_group_label>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Men with Breast Cancer</arm_group_label>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Men without Breast Cancer</arm_group_label>
    <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).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Population-based health and medical registries, prescription registries, and mortality&#xD;
        registries in Denmark, Finland, Norway, and Sweden&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant's study medical information available in population-based health and&#xD;
             medical registries, prescription registries, and mortality registries in Denmark,&#xD;
             Finland, Norway, or Sweden within the observation period of 1995 to 2013&#xD;
&#xD;
          -  Male with breast cancer with medical information in one of the 4 country-specific&#xD;
             registries in this study OR country- and age-matched control men without breast cancer&#xD;
             and with medical information in one of the 4 country-specific registries&#xD;
&#xD;
          -  Study participant's exposure to finasteride is available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For country- and age-matched control men without breast cancer&#xD;
&#xD;
          -  Previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer&#xD;
&#xD;
          -  Previous prostatectomy&#xD;
&#xD;
          -  Finasteride or dutasteride use (dutasteride is a drug in the same class as&#xD;
             finasteride) within first 6 months of registration in the prescription registers (new&#xD;
             user design).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Denmark</country>
  </removed_countries>
  <link>
    <url>http://www.encepp.eu/encepp/viewResource.htm?id=23230</url>
    <description>EU PAS link</description>
  </link>
  <results_reference>
    <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.</citation>
    <PMID>29239131</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Males breast cancer</keyword>
  <keyword>Finasteride</keyword>
  <keyword>PROSCAR®</keyword>
  <keyword>PROPECIA®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01703520
org study id: 0906-162
secondary id: 2003.021
nct id: NCT01703520
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year
time frame: Up to 14 years
measure: Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride
time frame: Up to 14 years
measure: Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride
time frame: Up to 14 years
measure: Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls
time frame: Up to 19 years
arm group 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).
arm group 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).
arm group 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).
arm group 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).
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Denmark
url: http://www.encepp.eu/encepp/viewResource.htm?id=23230
description: EU PAS link
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.
PMID: 29239131
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Neoplasms, Male
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php