<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/NCT03768258</url>
  </required_header>
  <id_info>
    <org_study_id>MW0318-TBCP10Y</org_study_id>
    <nct_id>NCT03768258</nct_id>
  </id_info>
  <brief_title>Testosterone Implants and the Incidence of Breast Cancer</brief_title>
  <acronym>TIBCaP</acronym>
  <official_title>Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Millennium Wellness LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Millennium Wellness LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This current chart review study was designed to investigate the incidence of breast cancer in&#xD;
      women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prior ten-year prospective, observational, study was initially approved in March of 2008 by&#xD;
      the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio&#xD;
      45005 and registered through the Office for Human Research Protections (OHRP). Expedited&#xD;
      approval continued annually through 2013 at which time the IRB board was closed. All&#xD;
      participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The&#xD;
      original protocol was designed to investigate the incidence of breast cancer in women&#xD;
      presenting with symptoms of hormone deficiency treated with subcutaneous testosterone&#xD;
      implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A&#xD;
      computer program was specifically designed to track and follow patients prospectively and all&#xD;
      patients continued to be followed through 2018.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2008</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Incidence of invasive breast cancer</measure>
    <time_frame>10-year results</time_frame>
    <description>The incidence of invasive breast cancer in women treated with testosterone therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of ductal carcinoma in situ</measure>
    <time_frame>10-year results</time_frame>
    <description>The incidence of DCIS in women treated with testosterone therapy</description>
  </secondary_outcome>
  <enrollment type="Actual">1268</enrollment>
  <condition>Breast Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone Implant</intervention_name>
    <description>Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency</description>
    <other_name>Testosterone + anastrozole implant</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who presented to the office of Dr. Rebecca Glaser between March 2008- March of 2103&#xD;
        with symptoms of hormone deficiency and received testosterone implant therapy were asked to&#xD;
        participate in the study. This current chart review study will examine the 10-year&#xD;
        incidence of breast cancer in women accrued to the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients treated between March 2008 - March 2013&#xD;
&#xD;
          -  Women who received at least two testosterone pellet insertion procedures&#xD;
&#xD;
          -  Women previously accrued to the prospective cohort study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing breast cancer&#xD;
&#xD;
          -  Women who received a single testosterone pellet insertion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>92 Years</maximum_age>
  </eligibility>
  <link>
    <url>https://link.springer.com/article/10.1186/s12885-019-6457-8#Sec16</url>
    <description>Statistical Methods and Results Additional File 1</description>
  </link>
  <results_reference>
    <citation>Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8.</citation>
    <PMID>31888528</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Millennium Wellness LLC</investigator_affiliation>
    <investigator_full_name>Rebecca L. Glaser, M.D.</investigator_full_name>
    <investigator_title>Physician, PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Anastrozole</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03768258
org study id: MW0318-TBCP10Y
nct id: NCT03768258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This current chart review study was designed to investigate the incidence of breast cancer in
      women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.
A prior ten-year prospective, observational, study was initially approved in March of 2008 by
      the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio
      45005 and registered through the Office for Human Research Protections (OHRP). Expedited
      approval continued annually through 2013 at which time the IRB board was closed. All
      participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The
      original protocol was designed to investigate the incidence of breast cancer in women
      presenting with symptoms of hormone deficiency treated with subcutaneous testosterone
      implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A
      computer program was specifically designed to track and follow patients prospectively and all
      patients continued to be followed through 2018.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of invasive breast cancer
time frame: 10-year results
description: The incidence of invasive breast cancer in women treated with testosterone therapy
measure: Incidence of ductal carcinoma in situ
time frame: 10-year results
description: The incidence of DCIS in women treated with testosterone therapy
intervention type: Drug
intervention name: Testosterone Implant
description: Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency
other name: Testosterone + anastrozole implant
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 24 Years
maximum age: 92 Years
url: https://link.springer.com/article/10.1186/s12885-019-6457-8#Sec16
description: Statistical Methods and Results Additional File 1
citation: Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8.
PMID: 31888528
responsible party type: Principal Investigator
investigator affiliation: Millennium Wellness LLC
investigator full name: Rebecca L. Glaser, M.D.
investigator title: Physician, PI
mesh term: Breast Neoplasms
mesh term: Methyltestosterone
mesh term: Anastrozole
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No