<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/NCT01715129</url>
  </required_header>
  <id_info>
    <org_study_id>8-55-52014-200</org_study_id>
    <secondary_id>2012-001279-35</secondary_id>
    <nct_id>NCT01715129</nct_id>
  </id_info>
  <brief_title>Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer</brief_title>
  <acronym>DKP 3M SC</acronym>
  <official_title>A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when&#xD;
      administered by subcutaneous route.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183</measure>
    <time_frame>At Day 29 and 183</time_frame>
    <description>Percentage of subjects castrated (i.e. with serum testosterone &lt;50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose</measure>
    <time_frame>At Day 92</time_frame>
    <description>Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probability of Testosterone &lt;50 ng/dL</measure>
    <time_frame>Day 29 through Day 183</time_frame>
    <description>Probability of testosterone &lt;50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.&#xD;
LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Demonstrating Castration With Testosterone Level &lt;50 ng/dL at Day 95</measure>
    <time_frame>Day 95</time_frame>
    <description>Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Achieve Castration (Tcast)</measure>
    <time_frame>Up to Day 36</time_frame>
    <description>Time to castration (Tcast) from first administration date until first observed serum testosterone level &lt;50 ng/dL or &lt;1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Triptorelin Levels (Cmin)</measure>
    <time_frame>At Day 92 and 183</time_frame>
    <description>Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects</measure>
    <time_frame>From Day 1 (Baseline) to Day 183 (End of study)</time_frame>
    <description>Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. &gt;4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)</measure>
    <time_frame>At Day 183</time_frame>
    <description>0-4 ng/mL (normal PSA value)&#xD;
&gt;4 ng/mL (abnormal PSA levels)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Apparent Tumor Progression</measure>
    <time_frame>Day 92 and 183</time_frame>
    <description>Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Adverse Events</measure>
    <time_frame>Up to Day 183</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (Tmax) of Triptorelin</measure>
    <time_frame>At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration Value (Cmax) of Triptorelin</measure>
    <time_frame>At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin</measure>
    <time_frame>At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Triptorelin in Subset of 18 Subjects</measure>
    <time_frame>At Day 92 and 183</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>11.25mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>11.25mg, SC on Day 1 and Day 92</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin Pamoate 11.25mg</intervention_name>
    <arm_group_label>11.25mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven locally advanced or metastatic prostate cancer who are suitable&#xD;
             for androgen deprivation therapy&#xD;
&#xD;
          -  Male aged ≥18 years old&#xD;
&#xD;
          -  Screening testosterone level of &gt;125 ng/dL&#xD;
&#xD;
          -  Life expectancy of greater than 12 months in the judgement of the Investigator&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1&#xD;
&#xD;
          -  Willing to give signed informed consent freely&#xD;
&#xD;
          -  Able to adhere to the study visit schedule and other protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior hormonal therapy for prostate cancer&#xD;
&#xD;
          -  Prior surgery or radiotherapy of prostate cancer with curative intent unless disease&#xD;
             is verified by a rising prostate specific antigen (PSA) concentration on follow up&#xD;
             (elevated PSA values on last two tests conducted at least a month apart) and the&#xD;
             patient is eligible for androgen deprivation therapy&#xD;
&#xD;
          -  Presence or history of any other malignancy except for non melanoma skin cancer&#xD;
             adequately treated at least 2 years before study entry&#xD;
&#xD;
          -  Painful local bone lesions or spinal lesions which may lead to compression&#xD;
&#xD;
          -  History of myocardial infarction, percutaneous coronary intervention, acute coronary&#xD;
             syndrome, coronary artery bypass graft, Class III/IV congestive heart failure,&#xD;
             cerebrovascular accident, transient ischaemic attack, or limb claudication at rest,&#xD;
             within six months prior to start of study treatment and ongoing symptomatic&#xD;
             dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or&#xD;
             uncontrolled ventricular arrhythmias&#xD;
&#xD;
          -  Any condition in opinion of the Investigator, including other active or latent&#xD;
             infections, medical or psychiatric conditions, or the presence of laboratory&#xD;
             abnormalities, which could confound the ability to interpret data from the study,&#xD;
             compromises the objective of the study or places the patient at unacceptable risk if&#xD;
             he participates in the study&#xD;
&#xD;
          -  Abnormal haematological, hepatic or renal functions:&#xD;
&#xD;
               -  Haemoglobin &lt;9 g/dL, absolute neutrophil count ≤1.5 x 10^9/L or platelets ≤100 x&#xD;
                  10^9/L&#xD;
&#xD;
               -  Serum creatinine ≥1.5 times the upper limit of normal (ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase or alanine aminotransferase &gt;2.5 times the ULN&#xD;
&#xD;
          -  Known hypersensitivity to the study treatment, to any of its excipients&#xD;
&#xD;
          -  Known active use of recreational drug or alcohol dependence in the opinion of the&#xD;
             Investigator&#xD;
&#xD;
          -  Any current use or use within six months prior to start of treatment, of medications&#xD;
             which are known to affect the metabolism and/or secretion of androgenic hormones: e.g.&#xD;
             ketoconazole, aminoglutethimide, oestrogens, and progesterone&#xD;
&#xD;
          -  Use of systemic corticosteroids (inhaled corticosteroids and topical application of&#xD;
             corticosteroids are permitted)&#xD;
&#xD;
          -  Aged ≥90 years for the main study and ≥80 years for those included in the&#xD;
             pharmacokinetic (PK) patient population&#xD;
&#xD;
          -  Participation in any other study or receipt of any investigational compound in the 30&#xD;
             days (or five times the elimination half life if this is longer) prior to study entry&#xD;
&#xD;
          -  Any skin or other condition that may preclude s.c. injection administration&#xD;
&#xD;
          -  Known brain or epidural metastases.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director, Uro-Oncology</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shumen</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Varna</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suresnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daugavpils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kutno</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Craiova</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>France</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>Romania</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>July 17, 2015</results_first_submitted>
  <results_first_submitted_qc>September 23, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 28, 2015</results_first_posted>
  <last_update_submitted>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triptorelin Pamoate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 139 subjects were screened and 13 subjects were screen failures.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Triptorelin Pamoate</title>
          <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event, fatal</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent Withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Triptorelin Pamoate</title>
          <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="126"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="70.4" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian / White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.2" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.6" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.16" spread="3.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prostate Specific Antigen (PSA)</title>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="133.53" spread="385.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183</title>
        <description>Percentage of subjects castrated (i.e. with serum testosterone &lt;50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183</description>
        <time_frame>At Day 29 and 183</time_frame>
        <population>N=Number of subjects attending the visit</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183</title>
          <description>Percentage of subjects castrated (i.e. with serum testosterone &lt;50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183</description>
          <population>N=Number of subjects attending the visit</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 (N=126)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6" lower_limit="93.2" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 183 (N=119)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6" lower_limit="91.6" upper_limit="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose</title>
        <description>Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.</description>
        <time_frame>At Day 92</time_frame>
        <population>Initially Castrated (IC1) population: All treated subjects with testosterone levels &lt;50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose</title>
          <description>Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.</description>
          <population>Initially Castrated (IC1) population: All treated subjects with testosterone levels &lt;50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2" lower_limit="95.4" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Probability of Testosterone &lt;50 ng/dL</title>
        <description>Probability of testosterone &lt;50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.&#xD;
LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry</description>
        <time_frame>Day 29 through Day 183</time_frame>
        <population>Intention-to-treat (ITT) population: All treated subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Probability of Testosterone &lt;50 ng/dL</title>
          <description>Probability of testosterone &lt;50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.&#xD;
LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry</description>
          <population>Intention-to-treat (ITT) population: All treated subjects</population>
          <units>Proportion of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" lower_limit="0.92" upper_limit="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Demonstrating Castration With Testosterone Level &lt;50 ng/dL at Day 95</title>
        <description>Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.</description>
        <time_frame>Day 95</time_frame>
        <population>IC1 population.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Demonstrating Castration With Testosterone Level &lt;50 ng/dL at Day 95</title>
          <description>Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.</description>
          <population>IC1 population.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.3" lower_limit="94.1" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Achieve Castration (Tcast)</title>
        <description>Time to castration (Tcast) from first administration date until first observed serum testosterone level &lt;50 ng/dL or &lt;1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)</description>
        <time_frame>Up to Day 36</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Achieve Castration (Tcast)</title>
          <description>Time to castration (Tcast) from first administration date until first observed serum testosterone level &lt;50 ng/dL or &lt;1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)</description>
          <population>ITT population</population>
          <units>Day</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="22" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Triptorelin Levels (Cmin)</title>
        <description>Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.</description>
        <time_frame>At Day 92 and 183</time_frame>
        <population>ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Triptorelin Levels (Cmin)</title>
          <description>Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.</description>
          <population>ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 92</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.062" spread="0.031"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 183 (N=117)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.049" spread="0.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects</title>
        <description>Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. &gt;4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.</description>
        <time_frame>From Day 1 (Baseline) to Day 183 (End of study)</time_frame>
        <population>ITT population at End of Study (Day 183). One subject had no data.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects</title>
          <description>Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. &gt;4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.</description>
          <population>ITT population at End of Study (Day 183). One subject had no data.</population>
          <units>Percentage Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-85.503" spread="42.410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)</title>
        <description>0-4 ng/mL (normal PSA value)&#xD;
&gt;4 ng/mL (abnormal PSA levels)</description>
        <time_frame>At Day 183</time_frame>
        <population>Subjects completed Day 183 visit (End of Study)</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)</title>
          <description>0-4 ng/mL (normal PSA value)&#xD;
&gt;4 ng/mL (abnormal PSA levels)</description>
          <population>Subjects completed Day 183 visit (End of Study)</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="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Study (0-4 ng/mL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study (&gt;4 ng/mL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Apparent Tumor Progression</title>
        <description>Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).</description>
        <time_frame>Day 92 and 183</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Apparent Tumor Progression</title>
          <description>Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).</description>
          <population>ITT population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 92: Non Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 92: Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 183: Non Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 183: Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Adverse Events</title>
        <time_frame>Up to Day 183</time_frame>
        <population>All subjects who received at least one dose of study treatment were included in safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Adverse Events</title>
          <population>All subjects who received at least one dose of study treatment were included in safety population.</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="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Adverse Events (SAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment Emergent Adverse Events (TEAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Leading to Withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Grade NCI-CTC of TEAEs: Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Grade NCI-CTC of TEAEs: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Grade NCI-CTC of TEAEs: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Grade NCI-CTC of TEAEs: Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Grade NCI-CTC of TEAEs: Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most serious causality of TEAEs: Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most serious causality of TEAEs: Not related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Cmax (Tmax) of Triptorelin</title>
        <time_frame>At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1</time_frame>
        <population>Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Cmax (Tmax) of Triptorelin</title>
          <population>Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.01" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Plasma Concentration Value (Cmax) of Triptorelin</title>
        <time_frame>At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1</time_frame>
        <population>PK profile was assessed in a subset of 18 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Plasma Concentration Value (Cmax) of Triptorelin</title>
          <population>PK profile was assessed in a subset of 18 subjects.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.58" spread="7.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin</title>
        <time_frame>At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1</time_frame>
        <population>PK profile was assessed in a subset of 18 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin</title>
          <population>PK profile was assessed in a subset of 18 subjects.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="304.6" spread="103.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmin of Triptorelin in Subset of 18 Subjects</title>
        <time_frame>At Day 92 and 183</time_frame>
        <population>Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate</title>
            <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
          </group>
        </group_list>
        <measure>
          <title>Cmin of Triptorelin in Subset of 18 Subjects</title>
          <population>Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 92 (N=14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.078" spread="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 183 (N=18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.062" spread="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 183</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Triptorelin Pamoate 11.25 mg</title>
          <description>Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</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="6" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fibula Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="45" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Injection Site Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Tooth Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </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="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Fibula Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="12" subjects_affected="4" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Loss Of Consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anger</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile Dysfunction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Breast Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Breast Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Breast Tenderness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Night Sweats</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Hypotrichosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director, Oncology</name_or_title>
      <organization>Ipsen</organization>
      <phone>clinical.trials@ipsen.com</phone>
      <email>clinical.trials@ipsen.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/NCT01715129
org study id: 8-55-52014-200
secondary id: 2012-001279-35
nct id: NCT01715129
lead sponsor: 
has dmc: No
Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when
      administered by subcutaneous route.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183
time frame: At Day 29 and 183
description: Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183
measure: Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose
time frame: At Day 92
description: Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.
measure: Probability of Testosterone <50 ng/dL
time frame: Day 29 through Day 183
description: Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.
LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry
measure: Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95
time frame: Day 95
description: Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.
measure: Time to Achieve Castration (Tcast)
time frame: Up to Day 36
description: Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)
measure: Plasma Triptorelin Levels (Cmin)
time frame: At Day 92 and 183
description: Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.
measure: Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects
time frame: From Day 1 (Baseline) to Day 183 (End of study)
description: Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.
measure: Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)
time frame: At Day 183
description: 0-4 ng/mL (normal PSA value)
>4 ng/mL (abnormal PSA levels)
measure: Clinically Apparent Tumor Progression
time frame: Day 92 and 183
description: Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).
measure: Percentage of Subjects With Adverse Events
time frame: Up to Day 183
measure: Time to Cmax (Tmax) of Triptorelin
time frame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1
measure: Peak Plasma Concentration Value (Cmax) of Triptorelin
time frame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1
measure: Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin
time frame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1
measure: Cmin of Triptorelin in Subset of 18 Subjects
time frame: At Day 92 and 183
arm group label: 11.25mg
arm group type: Experimental
description: 11.25mg, SC on Day 1 and Day 92
intervention type: Drug
intervention name: Triptorelin Pamoate 11.25mg
arm group label: 11.25mg
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director, Uro-Oncology
role: Study Director
affiliation: Ipsen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: France
country: Latvia
country: Poland
country: Romania
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Triptorelin Pamoate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 