<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/NCT02212197</url>
  </required_header>
  <id_info>
    <org_study_id>HS-12-460</org_study_id>
    <nct_id>NCT02212197</nct_id>
  </id_info>
  <brief_title>Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer</brief_title>
  <official_title>A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Camurus AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Camurus AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and&#xD;
      safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive&#xD;
      leuprolide acetate administered subcutaneously once monthly during 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3</measure>
    <time_frame>84 days</time_frame>
    <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Half-life (t½) for Dose 1 and Dose 3</measure>
    <time_frame>Days 0-28 and Days 56-84</time_frame>
    <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3</measure>
    <time_frame>Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)</time_frame>
    <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time (Days) to Testosterone Recovery After Dose 3</measure>
    <time_frame>Days 56-126</time_frame>
    <description>The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)</measure>
    <time_frame>Days 0-126</time_frame>
    <description>The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Prostate Specific Antigen (PSA) Concentration</measure>
    <time_frame>Days 0-126</time_frame>
    <description>The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>CAM2032 3.75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAM2032 7.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eligard 7.5 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>leuprolide acetate FluidCrystal® injection depot</intervention_name>
    <arm_group_label>CAM2032 3.75 mg</arm_group_label>
    <arm_group_label>CAM2032 7.5 mg</arm_group_label>
    <other_name>CAM2032</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>leuprolide acetate</intervention_name>
    <arm_group_label>Eligard 7.5 mg</arm_group_label>
    <other_name>Eligard</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men ≥40 and ≤85 years of age&#xD;
&#xD;
          -  Histological or cytological proven adenocarcinoma of the prostate requiring hormone&#xD;
             therapy&#xD;
&#xD;
          -  Life expectancy over 12 months&#xD;
&#xD;
          -  World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG)&#xD;
             performance status of 0, 1 or 2&#xD;
&#xD;
          -  Adequate and stable renal function&#xD;
&#xD;
          -  Adequate and stable hepatic function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction&#xD;
&#xD;
          -  Serum Testosterone levels below 150 ng/dL at Screening visit&#xD;
&#xD;
          -  Medical or radiological prostate cancer treatments within 2 months prior to the&#xD;
             Screening visit&#xD;
&#xD;
          -  Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit&#xD;
&#xD;
          -  Prior orchiectomy, hypophysectomy, or adrenalectomy&#xD;
&#xD;
          -  Prior use of LHRH agonists within 12 months prior to the Screening visit and during&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teuvo Tammela, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Docrates Cancer Center</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Helsinki, Department of Urology</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital, Department of Urology</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Turku, Department of Urology</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University Hospital Department of Urology</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Imre Teaching Hospital</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Debrecen, Medical Health Sciences Center, Department of Urology</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Hungary</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>December 12, 2016</results_first_submitted>
  <results_first_submitted_qc>December 12, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 6, 2017</results_first_posted>
  <last_update_submitted>March 15, 2017</last_update_submitted>
  <last_update_submitted_qc>March 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>leuprolide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CAM2032 3.75 mg</title>
          <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="P2">
          <title>CAM2032 7.5 mg</title>
          <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="P3">
          <title>Eligard 7.5 mg</title>
          <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Need for radiotherapy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CAM2032 3.75 mg</title>
          <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="B2">
          <title>CAM2032 7.5 mg</title>
          <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="B3">
          <title>Eligard 7.5 mg</title>
          <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="B4">
          <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="19"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="51"/>
          </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="42"/>
                  </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="69.7" spread="9.5"/>
                    <measurement group_id="B2" value="71.9" spread="6.3"/>
                    <measurement group_id="B3" value="70.9" spread="7"/>
                    <measurement group_id="B4" value="70.8" spread="7.8"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="51"/>
                  </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>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3</title>
        <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).</description>
        <time_frame>84 days</time_frame>
        <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
        <group_list>
          <group group_id="O1">
            <title>CAM2032 3.75 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O2">
            <title>CAM2032 7.5 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O3">
            <title>Eligard 7.5 mg</title>
            <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3</title>
          <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).</description>
          <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.14" spread="41.1"/>
                    <measurement group_id="O2" value="9.66" spread="31.5"/>
                    <measurement group_id="O3" value="13.6" spread="54.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" spread="33.3"/>
                    <measurement group_id="O2" value="11.3" spread="36.8"/>
                    <measurement group_id="O3" value="12.1" spread="47.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Half-life (t½) for Dose 1 and Dose 3</title>
        <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.</description>
        <time_frame>Days 0-28 and Days 56-84</time_frame>
        <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
        <group_list>
          <group group_id="O1">
            <title>CAM2032 3.75 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O2">
            <title>CAM2032 7.5 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O3">
            <title>Eligard 7.5 mg</title>
            <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t½) for Dose 1 and Dose 3</title>
          <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.</description>
          <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205" spread="113"/>
                    <measurement group_id="O2" value="231" spread="142"/>
                    <measurement group_id="O3" value="743" spread="1677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299" spread="277"/>
                    <measurement group_id="O2" value="434" spread="867"/>
                    <measurement group_id="O3" value="378" spread="570"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3</title>
        <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.</description>
        <time_frame>Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)</time_frame>
        <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
        <group_list>
          <group group_id="O1">
            <title>CAM2032 3.75 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O2">
            <title>CAM2032 7.5 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O3">
            <title>Eligard 7.5 mg</title>
            <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3</title>
          <description>Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.</description>
          <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329" spread="37.6"/>
                    <measurement group_id="O2" value="622" spread="45.2"/>
                    <measurement group_id="O3" value="397" spread="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343" spread="24.7"/>
                    <measurement group_id="O2" value="757" spread="53.4"/>
                    <measurement group_id="O3" value="460" spread="62.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time (Days) to Testosterone Recovery After Dose 3</title>
        <description>The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.</description>
        <time_frame>Days 56-126</time_frame>
        <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
        <group_list>
          <group group_id="O1">
            <title>CAM2032 3.75 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O2">
            <title>CAM2032 7.5 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O3">
            <title>Eligard 7.5 mg</title>
            <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
          </group>
        </group_list>
        <measure>
          <title>Time (Days) to Testosterone Recovery After Dose 3</title>
          <description>The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.</description>
          <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2" spread="13.6"/>
                    <measurement group_id="O2" value="52.3" spread="20.6"/>
                    <measurement group_id="O3" value="65" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)</title>
        <description>The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.</description>
        <time_frame>Days 0-126</time_frame>
        <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
        <group_list>
          <group group_id="O1">
            <title>CAM2032 3.75 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O2">
            <title>CAM2032 7.5 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O3">
            <title>Eligard 7.5 mg</title>
            <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
          </group>
        </group_list>
        <measure>
          <title>Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)</title>
          <description>The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.</description>
          <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
          <units>ng/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="443" lower_limit="369" upper_limit="546"/>
                    <measurement group_id="O2" value="321" lower_limit="269" upper_limit="439"/>
                    <measurement group_id="O3" value="350" lower_limit="240" upper_limit="465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="18.3" upper_limit="47"/>
                    <measurement group_id="O2" value="24.5" lower_limit="16.1" upper_limit="210"/>
                    <measurement group_id="O3" value="18.1" lower_limit="11.1" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" lower_limit="10.7" upper_limit="19.3"/>
                    <measurement group_id="O2" value="13.8" lower_limit="7.8" upper_limit="22"/>
                    <measurement group_id="O3" value="12" lower_limit="9.29" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" lower_limit="9.17" upper_limit="27.6"/>
                    <measurement group_id="O2" value="10.6" lower_limit="7.5" upper_limit="18.8"/>
                    <measurement group_id="O3" value="12.4" lower_limit="9.92" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="423" lower_limit="258" upper_limit="526"/>
                    <measurement group_id="O2" value="278" lower_limit="124" upper_limit="470"/>
                    <measurement group_id="O3" value="85.8" lower_limit="16" upper_limit="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Prostate Specific Antigen (PSA) Concentration</title>
        <description>The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.</description>
        <time_frame>Days 0-126</time_frame>
        <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
        <group_list>
          <group group_id="O1">
            <title>CAM2032 3.75 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O2">
            <title>CAM2032 7.5 mg</title>
            <description>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.</description>
          </group>
          <group group_id="O3">
            <title>Eligard 7.5 mg</title>
            <description>Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Prostate Specific Antigen (PSA) Concentration</title>
          <description>The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.</description>
          <population>The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="5.8" upper_limit="85.4"/>
                    <measurement group_id="O2" value="18.8" lower_limit="9.6" upper_limit="93.5"/>
                    <measurement group_id="O3" value="14.6" lower_limit="4.7" upper_limit="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="2.8" upper_limit="19"/>
                    <measurement group_id="O2" value="8.3" lower_limit="5.9" upper_limit="31.5"/>
                    <measurement group_id="O3" value="4.6" lower_limit="2.3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="1.1" upper_limit="8.4"/>
                    <measurement group_id="O2" value="5.8" lower_limit="1.1" upper_limit="11.2"/>
                    <measurement group_id="O3" value="2.1" lower_limit="0.8" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.1" upper_limit="5.6"/>
                    <measurement group_id="O2" value="2.6" lower_limit="0.8" upper_limit="14"/>
                    <measurement group_id="O3" value="1.6" lower_limit="0.4" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="2.9" upper_limit="19.9"/>
                    <measurement group_id="O2" value="3.1" lower_limit="1.5" upper_limit="19.1"/>
                    <measurement group_id="O3" value="1.6" lower_limit="0.5" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>CAM2032 3.75 mg</title>
          <description>Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="E2">
          <title>CAM2032 7.5 mg</title>
          <description>Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.</description>
        </group>
        <group group_id="E3">
          <title>Eligard 7.5 mg</title>
          <description>Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.</description>
        </group>
      </group_list>
      <serious_events>
        <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="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Arrhytmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </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="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood urine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Muscle spasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Haemorrhage urinary tract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Micturition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bladder pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Urethral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Genital pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="19"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Manager</name_or_title>
      <organization>Camurus AB</organization>
      <email>info@camurus.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/NCT02212197
org study id: HS-12-460
nct id: NCT02212197
lead sponsor: 
has dmc: No
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and
      safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive
      leuprolide acetate administered subcutaneously once monthly during 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
time frame: 84 days
description: Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).
measure: Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
time frame: Days 0-28 and Days 56-84
description: Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.
measure: Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
time frame: Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
description: Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.
measure: Time (Days) to Testosterone Recovery After Dose 3
time frame: Days 56-126
description: The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
measure: Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
time frame: Days 0-126
description: The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
measure: Mean Prostate Specific Antigen (PSA) Concentration
time frame: Days 0-126
description: The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.
arm group label: CAM2032 3.75 mg
arm group type: Experimental
description: Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
arm group label: CAM2032 7.5 mg
arm group type: Experimental
description: Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
arm group label: Eligard 7.5 mg
arm group type: Active Comparator
description: Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
intervention type: Drug
intervention name: leuprolide acetate FluidCrystal® injection depot
arm group label: CAM2032 3.75 mg
arm group label: CAM2032 7.5 mg
other name: CAM2032
intervention type: Drug
intervention name: leuprolide acetate
arm group label: Eligard 7.5 mg
other name: Eligard
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Teuvo Tammela, Prof
role: Principal Investigator
affiliation: Tampere University Hospital
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country: Finland
country: Hungary
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Leuprolide
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
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