<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/NCT01699178</url>
  </required_header>
  <id_info>
    <org_study_id>CLAR-12010</org_study_id>
    <nct_id>NCT01699178</nct_id>
  </id_info>
  <brief_title>Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men</brief_title>
  <official_title>Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clarus Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clarus Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this one year extension (follow-up) study is to gather additional safety data&#xD;
      in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III&#xD;
      study CLAR-09007.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an&#xD;
      open-label study. This study contained an arm to evaluate the oral TU formulation as well as&#xD;
      a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was&#xD;
      included in the Phase III study and in this extension study to allow a general evaluation of&#xD;
      comparative safety. Subjects randomized to oral TU in the Phase III study were continued on&#xD;
      oral TU in the extension, and those who completed this 12-month Phase IV study have been&#xD;
      followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to&#xD;
      transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those&#xD;
      who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel&#xD;
      therapy. This 2-year period of therapy and assessments was to provide a long-term view of the&#xD;
      safety of oral TU and the stability of the T replacement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change From Baseline in T Cholesterol</measure>
    <time_frame>Approximately 365 days</time_frame>
    <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in HDL</measure>
    <time_frame>Approximately 365 days</time_frame>
    <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in LDL</measure>
    <time_frame>Approximately 365 days</time_frame>
    <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Hgb</measure>
    <time_frame>Approximately 365 days</time_frame>
    <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Hct</measure>
    <time_frame>Approximately 365 days</time_frame>
    <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Prostate Volume</measure>
    <time_frame>Approximately 365 days</time_frame>
    <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Male Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Oral testosterone undecanoate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transdermal testosterone gel (AndroGel)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral testosterone undecanoate</intervention_name>
    <description>Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID</description>
    <arm_group_label>Oral testosterone undecanoate</arm_group_label>
    <other_name>Oral TU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Transdermal testosterone gel (AndroGel)</intervention_name>
    <description>Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD</description>
    <arm_group_label>Transdermal testosterone gel (AndroGel)</arm_group_label>
    <other_name>AndroGel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects were to have completed Study CLAR-09007.&#xD;
&#xD;
          2. Subjects were to have adequate venous access in the left or right arm to allow&#xD;
             collection of a number of blood samples via a venous cannula.&#xD;
&#xD;
          3. Subjects were required to remain off all forms of T except for study medication&#xD;
             throughout the entire study.&#xD;
&#xD;
          4. Subjects voluntarily gave written informed consent to participate in this study.&#xD;
&#xD;
        Subjects meeting any of the following criteria were not eligible for participation in this&#xD;
        study:&#xD;
&#xD;
          1. Significant intercurrent disease of any type, in particular liver, kidney,&#xD;
             uncontrolled or poorly controlled heart disease, or psychiatric illness developed&#xD;
             during the Phase III study that would, in the opinion of the Investigator, require&#xD;
             exclusion from this study.&#xD;
&#xD;
          2. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).&#xD;
&#xD;
          3. Serum transaminases &gt;2 times upper limit of normal (ULN), serum bilirubin &gt;2.0 mg/dL&#xD;
             and serum creatinine &gt;2.0 mg/dL at the final visit for Study CLAR 09007.&#xD;
&#xD;
          4. Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA&#xD;
             (serum PSA &gt;4 ng/mL) at the final visit for Study CLAR-09007.&#xD;
&#xD;
          5. Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary&#xD;
             supplements that may increase serum T, such as androstenedione or&#xD;
             dehydroepiandrosterone (DHEA).&#xD;
&#xD;
          6. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors&#xD;
             (e.g., orlistat [Xenical]) and bile acid-binding resins (e.g., cholestyramine&#xD;
             [Questran], colestipol [Colestid]).&#xD;
&#xD;
          7. Poor compliers with study medication, study procedures, or study visits in Study CLAR&#xD;
             09007.&#xD;
&#xD;
          8. Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g.,&#xD;
             barbiturates, glucocorticoids [pharmacologic doses of glucocorticoids for replacement&#xD;
             therapy were not exclusionary]) and potent CYP3A4 inhibitors (e.g., human&#xD;
             immunodeficiency virus [HIV] antivirals [indinavir, nelfinavir, ritonavir, saquinavir,&#xD;
             delaviridine], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note:&#xD;
             Short-term ciprofloxacin administration completed more than 7 days prior to study&#xD;
             visits was not exclusionary during the study.)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Swerdloff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics, Inc.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Internal Medicine, PC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics</name>
      <address>
        <city>Calera</city>
        <state>Alabama</state>
        <zip>35040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Affiliated Research Center, Inc</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality of Life Medical and Research Centers, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Clinical Research</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Orange County Endocrinology</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tower Urology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Geffen School of Medicine, UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbor-UCLA Medical Center, LA Biomedical Research Institute</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Center/ConnecTrials</name>
      <address>
        <city>Middlebury</city>
        <state>Connecticut</state>
        <zip>06762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of CT School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Medical Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University School of Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruce R. Gilbert, MD, PhD</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Urology Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael A. Werner</name>
      <address>
        <city>Purchase</city>
        <state>New York</state>
        <zip>10577</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunstone Medical Research</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologic Consultants of Southeast Pennsylvania</name>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bonn, Clinic for Dermatology and Allergy</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Halle, Center for Reproduction and Andrology</name>
      <address>
        <city>Halle</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Szymula</name>
      <address>
        <city>Leipzig</city>
        <zip>04105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Schulze</name>
      <address>
        <city>Markkleeberg</city>
        <zip>04416</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Muenster, Center for Reproduction and Andrology</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>July 16, 2018</results_first_submitted>
  <results_first_submitted_qc>October 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2018</results_first_posted>
  <last_update_submitted>June 25, 2021</last_update_submitted>
  <last_update_submitted_qc>June 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</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>
    <ipd_description>Individual Participant data shared with associated investigational sites only.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Testosterone Undecanoate</title>
          <description>Oral testosterone undecanoate 100-300 mg T BID, for 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Transdermal Testosterone Gel (AndroGel)</title>
          <description>Transdermal testosterone gel 2.5-10 g/applied once daily for 12 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hematocrit &gt;54%</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>PSA increase of &gt;1.4 ng/mL</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>ineligible/noncompliant/ subject reason</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects were to have completed Study CLAR-09007.&#xD;
Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.&#xD;
Subjects were required to remain off all forms of T except for study medication throughout the entire study.</population>
      <group_list>
        <group group_id="B1">
          <title>Oral Testosterone Undecanoate</title>
          <description>Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.&#xD;
Oral testosterone undecanoate: Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID</description>
        </group>
        <group group_id="B2">
          <title>Transdermal Testosterone Gel (AndroGel)</title>
          <description>Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months&#xD;
Transdermal testosterone gel (AndroGel): Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
            <count group_id="B2" value="94"/>
            <count group_id="B3" value="182"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.2" spread="10.04"/>
                    <measurement group_id="B2" value="56.8" spread="11.23"/>
                    <measurement group_id="B3" value="56.5" spread="10.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in T Cholesterol</title>
        <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
        <time_frame>Approximately 365 days</time_frame>
        <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral TU</title>
            <description>Subjects treated with Oral TU</description>
          </group>
          <group group_id="O2">
            <title>Transdermal T-gel</title>
            <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in T Cholesterol</title>
          <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
          <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-8.4" upper_limit="8.9"/>
                    <measurement group_id="O2" value="8.2" lower_limit="-0.1" upper_limit="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in HDL</title>
        <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
        <time_frame>Approximately 365 days</time_frame>
        <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral TU</title>
            <description>Subjects treated with Oral TU</description>
          </group>
          <group group_id="O2">
            <title>Transdermal T-gel</title>
            <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in HDL</title>
          <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
          <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="0.7" upper_limit="4.1"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.5" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in LDL</title>
        <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
        <time_frame>Approximately 365 days</time_frame>
        <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral TU</title>
            <description>Subjects treated with Oral TU</description>
          </group>
          <group group_id="O2">
            <title>Transdermal T-gel</title>
            <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in LDL</title>
          <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
          <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" lower_limit="-9.5" upper_limit="6.5"/>
                    <measurement group_id="O2" value="6.0" lower_limit="-1.2" upper_limit="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Hgb</title>
        <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
        <time_frame>Approximately 365 days</time_frame>
        <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral TU</title>
            <description>Subjects treated with Oral TU</description>
          </group>
          <group group_id="O2">
            <title>Transdermal T-gel</title>
            <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Hgb</title>
          <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
          <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" lower_limit="0.11" upper_limit="0.61"/>
                    <measurement group_id="O2" value="0.36" lower_limit="0.07" upper_limit="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Hct</title>
        <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
        <time_frame>Approximately 365 days</time_frame>
        <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral TU</title>
            <description>Subjects treated with Oral TU</description>
          </group>
          <group group_id="O2">
            <title>Transdermal T-gel</title>
            <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Hct</title>
          <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
          <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" lower_limit="-0.30" upper_limit="1.06"/>
                    <measurement group_id="O2" value="0.37" lower_limit="-0.44" upper_limit="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Prostate Volume</title>
        <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
        <time_frame>Approximately 365 days</time_frame>
        <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral TU</title>
            <description>Subjects treated with Oral TU</description>
          </group>
          <group group_id="O2">
            <title>Transdermal T-gel</title>
            <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Prostate Volume</title>
          <description>Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.</description>
          <population>The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.</population>
          <units>cc</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" lower_limit="-0.78" upper_limit="2.97"/>
                    <measurement group_id="O2" value="0.40" lower_limit="-1.81" upper_limit="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>365 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Oral TU</title>
          <description>Subjects treated with Oral TU with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.</description>
        </group>
        <group group_id="E2">
          <title>Transdermal T-gel</title>
          <description>Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Prinzmetal angina</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>gastric ulcer hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>sepsis</sub_title>
                <description>Same subject as reported for prostate cancer 102-036</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <description>Same subject as SAE reported for Sepsis 102-036</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar Infarction</sub_title>
                <description>Same subject as SAE of Cerebrovascular Accident 101-043</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <description>Same subject as SAE of Cerebellar Infarction 101-043</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Alcohol detoxification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Polycythemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="88"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="88"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Hematocrit Increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PSA Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Invertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Theodore Danoff, MD, PhD</name_or_title>
      <organization>Clarus Therapeutics</organization>
      <phone>847-562-4300</phone>
      <email>tdanoff@clarustherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01699178
org study id: CLAR-12010
nct id: NCT01699178
lead sponsor: 
has dmc: No
The purpose of this one year extension (follow-up) study is to gather additional safety data
      in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III
      study CLAR-09007.
This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an
      open-label study. This study contained an arm to evaluate the oral TU formulation as well as
      a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was
      included in the Phase III study and in this extension study to allow a general evaluation of
      comparative safety. Subjects randomized to oral TU in the Phase III study were continued on
      oral TU in the extension, and those who completed this 12-month Phase IV study have been
      followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to
      transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those
      who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel
      therapy. This 2-year period of therapy and assessments was to provide a long-term view of the
      safety of oral TU and the stability of the T replacement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Change From Baseline in T Cholesterol
time frame: Approximately 365 days
description: Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
measure: Absolute Change From Baseline in HDL
time frame: Approximately 365 days
description: Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
measure: Absolute Change From Baseline in LDL
time frame: Approximately 365 days
description: Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
measure: Absolute Change From Baseline in Hgb
time frame: Approximately 365 days
description: Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
measure: Absolute Change From Baseline in Hct
time frame: Approximately 365 days
description: Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
measure: Absolute Change From Baseline in Prostate Volume
time frame: Approximately 365 days
description: Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
arm group label: Oral testosterone undecanoate
arm group type: Experimental
description: Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
arm group label: Transdermal testosterone gel (AndroGel)
arm group type: Active Comparator
description: Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
intervention type: Drug
intervention name: Oral testosterone undecanoate
description: Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
arm group label: Oral testosterone undecanoate
other name: Oral TU
intervention type: Drug
intervention name: Transdermal testosterone gel (AndroGel)
description: Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
arm group label: Transdermal testosterone gel (AndroGel)
other name: AndroGel
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ronald Swerdloff, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
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country: Germany
country: United States
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No
ipd description: Individual Participant data shared with associated investigational sites only.
participant flow: 
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