<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/NCT02222558</url>
  </required_header>
  <id_info>
    <org_study_id>TT-006</org_study_id>
    <nct_id>NCT02222558</nct_id>
  </id_info>
  <brief_title>Oral Testosterone for the Treatment of Hypogonadism in Males</brief_title>
  <official_title>A Phase 2B Study to Determine the Dose Response Pharmacokinetics of TSX-002 (Testosterone) in Hypogonadal Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TesoRx Pharma, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TesoRx Pharma, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low testosterone is a condition that occurs when the body is unable to produce sufficient&#xD;
      quantities of testosterone. The medical name for low testosterone is hypogonadism.&#xD;
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of&#xD;
      energy and mood swings. The goal of testosterone replacement therapy is to return&#xD;
      testosterone levels to the normal range and relieve symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone&#xD;
      after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men.&#xD;
      This will be determined by blood sampling at specified times during the study. The study is&#xD;
      also intended to evaluate the PK parameters of the testosterone metabolite,&#xD;
      dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study&#xD;
      consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study&#xD;
      duration is approximately 9 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2</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>Percentage of Responders</measure>
    <time_frame>Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24</time_frame>
    <description>Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Period 1: Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 2: Two Times Daily Dosing 90 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 3: Two Times Daily Dosing 120 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 3: Three Times Daily Dosing 90 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 3: Two Times Daily Dosing 180 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 3: Three Times Daily Dosing 120 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TSX-002</intervention_name>
    <description>TSX-002 are capsules with testosterone as the active ingredient.</description>
    <arm_group_label>Period 1: Single Dose</arm_group_label>
    <arm_group_label>Period 2: Two Times Daily Dosing 90 mg</arm_group_label>
    <arm_group_label>Period 3: Three Times Daily Dosing 120 mg</arm_group_label>
    <arm_group_label>Period 3: Three Times Daily Dosing 90 mg</arm_group_label>
    <arm_group_label>Period 3: Two Times Daily Dosing 120 mg</arm_group_label>
    <arm_group_label>Period 3: Two Times Daily Dosing 180 mg</arm_group_label>
    <other_name>Testosterone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic hypogonadal male subjects (Testosterone &gt; 100 and &lt;300 ng/dL, two separate&#xD;
             10 am samples one week apart),&#xD;
&#xD;
          -  18-70 years old,&#xD;
&#xD;
          -  Willing and able to provide informed consent and to participate in all 3 periods of&#xD;
             the study.&#xD;
&#xD;
          -  BMI &lt; 35 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease,&#xD;
             Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel&#xD;
             syndrome, Lactose intolerance);&#xD;
&#xD;
          -  Alcoholics or substance abuse;&#xD;
&#xD;
          -  Gastroparesis; IPSS (International Prostate Symptom score) &gt; 19; PSA&#xD;
             (prostate-specific antigen)&gt; 4 ng/ml;&#xD;
&#xD;
          -  Congestive Heart Failure, uncontrolled (NYHC &gt;1);&#xD;
&#xD;
          -  Uncontrolled sleep apnea;&#xD;
&#xD;
          -  Topical or injectable testosterone replacement therapy (any kind including&#xD;
             dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;&#xD;
&#xD;
          -  Testopel excluded if within 2 years;&#xD;
&#xD;
          -  Aveed excluded if within past 6 months;&#xD;
&#xD;
          -  Hematocrit &gt; 50.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irwin Goldstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego Sexual Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego Sexual Medicine</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <results_first_submitted>March 16, 2016</results_first_submitted>
  <results_first_submitted_qc>April 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 2016</results_first_posted>
  <last_update_submitted>April 21, 2016</last_update_submitted>
  <last_update_submitted_qc>April 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypogonadism</keyword>
  <keyword>Gonadal Disorders</keyword>
  <keyword>Endocrine System Diseases</keyword>
  <keyword>Testosterone</keyword>
  <keyword>Testosterone enanthate</keyword>
  <keyword>Testosterone undecanoate</keyword>
  <keyword>Testosterone 17 beta-cypionate</keyword>
  <keyword>Methyltestosterone</keyword>
  <keyword>Androgens</keyword>
  <keyword>Hormones</keyword>
  <keyword>Hormones,</keyword>
  <keyword>Hormone Substitutes,</keyword>
  <keyword>Hormone Antagonists</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Anabolic Agents</keyword>
  <keyword>dihydrotestosterone</keyword>
  <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>Testosterone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The planned enrollment for this study was up to 28 subjects. The actual enrollment of the study was 25 subjects, all of whom were included in the safety and PK evaluable populations. This was a single-center study conducted at San Diego Sexual Medicine medical clinic. First patient screened 27Aug2014, FPE 05Sep2014, LPE 28Jan2015, LPLV 24Apr2015.</recruitment_details>
      <pre_assignment_details>Period 1: Each study subject received 5 escalating single doses of TSX-002. Period 2: Each study subject dose was 90 mg BID of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level was drawn and used to determine eligibility for randomization to a further treatment group (BID vs. TID) or continuation in a BID treatment regimen.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Period 1: Single Dose</title>
          <description>Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.</description>
        </group>
        <group group_id="P2">
          <title>Period 2: Two Times Daily Dosing 90 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.</description>
        </group>
        <group group_id="P3">
          <title>Period 3: Two Times Daily Dosing 120 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
        <group group_id="P4">
          <title>Period 3: Three Times Daily Dosing 90 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
        <group group_id="P5">
          <title>Period 3: Two Times Daily Dosing 180 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
        <group group_id="P6">
          <title>Period 3: Three Times Daily Dosing 120 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1: Single Dose</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2: Two Times Daily Dosing 90 mg</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects that began each defined period.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.&#xD;
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.4" lower_limit="31" upper_limit="70"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </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="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Responders</title>
        <description>Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.</description>
        <time_frame>Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24</time_frame>
        <population>Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Period 1: Single Dose</title>
            <description>Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.</description>
          </group>
          <group group_id="O2">
            <title>Period 2: Two Times Daily Dosing 90 mg</title>
            <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.</description>
          </group>
          <group group_id="O3">
            <title>Period 3: Two Times Daily Dosing 120 mg</title>
            <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
          </group>
          <group group_id="O4">
            <title>Period 3: Three Times Daily Dosing 90 mg</title>
            <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
          </group>
          <group group_id="O5">
            <title>Period 3: Two Times Daily Dosing 180 mg</title>
            <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
          </group>
          <group group_id="O6">
            <title>Period 3: Three Times Daily Dosing 120 mg</title>
            <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders</title>
          <description>Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.</description>
          <population>Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="50"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="25"/>
                    <measurement group_id="O6" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.</time_frame>
      <desc>An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question &quot;How have you been feeling since you were last asked?&quot; at all visits from Day 0 to Exit.&#xD;
Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).</desc>
      <group_list>
        <group group_id="E1">
          <title>Period 1: Single Dose</title>
          <description>Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.</description>
        </group>
        <group group_id="E2">
          <title>Period 2: Two Times Daily Dosing 90 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.</description>
        </group>
        <group group_id="E3">
          <title>Period 3: Two Times Daily Dosing 120 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
        <group group_id="E4">
          <title>Period 3: Three Times Daily Dosing 90 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
        <group group_id="E5">
          <title>Period 3: Two Times Daily Dosing 180 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
        <group group_id="E6">
          <title>Period 3: Three Times Daily Dosing 120 mg</title>
          <description>Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.&#xD;
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <description>Unrelated to study drug, due to muscle injury due to prolonged muscle compression. Lab abnormalities included acute renal failure secondary to rhabdomyolysis, hyperkalemia, high creatinine kinase, and high level of potassium.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</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="5" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Prostatic specific antigen increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </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>At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Oefelein, MD, Chief Medical Officer</name_or_title>
      <organization>TesoRx Pharma, LLC</organization>
      <phone>909-595-0500 ext 104</phone>
      <email>karl@tesorx.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/NCT02222558
org study id: TT-006
nct id: NCT02222558
lead sponsor: 
has dmc: No
Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone
      after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men.
      This will be determined by blood sampling at specified times during the study. The study is
      also intended to evaluate the PK parameters of the testosterone metabolite,
      dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study
      consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study
      duration is approximately 9 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Responders
time frame: Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24
description: Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.
arm group label: Period 1: Single Dose
arm group type: Experimental
description: Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
arm group label: Period 2: Two Times Daily Dosing 90 mg
arm group type: Experimental
description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
arm group label: Period 3: Two Times Daily Dosing 120 mg
arm group type: Experimental
description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
arm group label: Period 3: Three Times Daily Dosing 90 mg
arm group type: Experimental
description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
arm group label: Period 3: Two Times Daily Dosing 180 mg
arm group type: Experimental
description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
arm group label: Period 3: Three Times Daily Dosing 120 mg
arm group type: Experimental
description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
intervention type: Drug
intervention name: TSX-002
description: TSX-002 are capsules with testosterone as the active ingredient.
arm group label: Period 1: Single Dose
arm group label: Period 2: Two Times Daily Dosing 90 mg
arm group label: Period 3: Three Times Daily Dosing 120 mg
arm group label: Period 3: Three Times Daily Dosing 90 mg
arm group label: Period 3: Two Times Daily Dosing 120 mg
arm group label: Period 3: Two Times Daily Dosing 180 mg
other name: Testosterone
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Irwin Goldstein, MD
role: Principal Investigator
affiliation: San Diego Sexual Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Testosterone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 