<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/NCT03232281</url>
  </required_header>
  <id_info>
    <org_study_id>D-CN-52014-220</org_study_id>
    <nct_id>NCT03232281</nct_id>
  </id_info>
  <brief_title>Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis</brief_title>
  <official_title>A Phase III, Multicentre, Randomised, Open-label, Parallel, Active-controlled Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in&#xD;
      Chinese female subjects with endometriosis by demonstrating the non-inferiority of&#xD;
      triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate&#xD;
      PR 1-month formulation injected 3 times consecutively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Actual">November 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL).&#xD;
The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8</measure>
    <time_frame>Weeks 4 and 8</time_frame>
    <description>The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12</measure>
    <time_frame>Weeks 4, 8 and 12</time_frame>
    <description>The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12</measure>
    <time_frame>Baseline (Day 1) and Weeks 4, 8 and 12</time_frame>
    <description>Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm). Lower scores indicated a better outcome. Baseline was defined as the last available assessment prior to the first dose of study medication. The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean E2 Concentration at Weeks Baseline and 4, 8 and 12</measure>
    <time_frame>Baseline (Day 1) and Weeks 4, 8 and 12</time_frame>
    <description>The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12</measure>
    <time_frame>Baseline (Day 1) and Weeks 4, 8 and 12</time_frame>
    <description>The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12</measure>
    <time_frame>Baseline and Weeks 4, 8 and 12</time_frame>
    <description>The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Menses Recovery</measure>
    <time_frame>Baseline (Day 1) up to Week 40 (end of study visit)</time_frame>
    <description>Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period. Menses recovery status was assessed at all study visits from Day 1 to the end of study visit. The median time to menses recovery was analysed using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Triptorelin pamoate PR 3-month</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triptorelin acetate PR 1-month</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin Pamoate PR 3-month</intervention_name>
    <description>15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).</description>
    <arm_group_label>Triptorelin pamoate PR 3-month</arm_group_label>
    <other_name>Triptorelin pamoate for injection 15 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin Acetate PR 1-month</intervention_name>
    <description>3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)</description>
    <arm_group_label>Triptorelin acetate PR 1-month</arm_group_label>
    <other_name>Diphereline 3.75 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects aged from 18 to 45 years inclusive at the date of informed consent.&#xD;
&#xD;
          -  A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6&#xD;
             months prior to the screening visit.&#xD;
&#xD;
          -  A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years&#xD;
             prior to the screening visit.&#xD;
&#xD;
          -  Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period&#xD;
             of 6 months in the judgement of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A current history of undiagnosed abnormal genital bleeding.&#xD;
&#xD;
          -  Received treatment with a GnRH agonist within 6 months prior to the screening visit.&#xD;
&#xD;
          -  Received any other hormonal treatment within 3 months prior to the screening visit&#xD;
             (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).&#xD;
&#xD;
          -  Chronic pelvic pain that is not caused by endometriosis, that would interfere with the&#xD;
             assessment of endometriosis-associated pelvic pain.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Obstetrics and Gynecology Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510235</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan General Hospital</name>
      <address>
        <city>Haikou</city>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Hospital, School of Medicine Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital school of medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Maternity and Child Health Care Hospital</name>
      <address>
        <city>Nanjing</city>
        <zip>210004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital, Southeast University</name>
      <address>
        <city>Nanjing</city>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanning</city>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obstetrics and Gynaecology Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <zip>300211</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Jiangsu People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>September 16, 2021</results_first_submitted>
  <results_first_submitted_qc>September 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2021</results_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03232281/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03232281/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Female subjects aged from 18 to 45 years were recruited to this Phase 3 randomised, open-label study at 24 study centres in China between 28 July 2017 and 16 November 2019.</recruitment_details>
      <pre_assignment_details>Subjects who met the inclusion criteria and none of the exclusion criteria were randomised in a 1:1 ratio, stratified according to endometriotic surgical history and the severity of endometriosis-associated pelvic pain.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Triptorelin Pamoate PR 3-month</title>
          <description>Subjects received 15 milligrams (mg) triptorelin pamoate per injection, administered as an intramuscular (IM) injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
        </group>
        <group group_id="P2">
          <title>Triptorelin Acetate PR 1-month</title>
          <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 12</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 24</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics are presented for the randomised set.</population>
      <group_list>
        <group group_id="B1">
          <title>Triptorelin Pamoate PR 3-month</title>
          <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
        </group>
        <group group_id="B2">
          <title>Triptorelin Acetate PR 1-month</title>
          <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="150"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="300"/>
          </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="32.4" spread="6.1"/>
                    <measurement group_id="B2" value="32.6" spread="6.2"/>
                    <measurement group_id="B3" value="32.5" spread="6.1"/>
                  </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="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Chinese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="300"/>
                  </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>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12</title>
        <description>Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL).&#xD;
The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.</description>
        <time_frame>Week 12</time_frame>
        <population>The per protocol set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter, and without major protocol violations/deviations affecting the primary efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12</title>
          <description>Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL).&#xD;
The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.</description>
          <population>The per protocol set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter, and without major protocol violations/deviations affecting the primary efficacy endpoint.</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="142"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="96.65" upper_limit="100.00"/>
                    <measurement group_id="O2" value="99.3" lower_limit="97.98" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI for the difference was &gt;-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was confirmed.</non_inferiority_desc>
            <param_type>Rate difference (%)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.41</ci_lower_limit>
            <ci_upper_limit>2.58</ci_upper_limit>
            <estimate_desc>The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8</title>
        <description>The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.</description>
        <time_frame>Weeks 4 and 8</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8</title>
          <description>The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</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="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="95.67" upper_limit="100.00"/>
                    <measurement group_id="O2" value="99.3" lower_limit="98.03" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="94.65" upper_limit="99.91"/>
                    <measurement group_id="O2" value="100.0" lower_limit="100.00" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI for the difference was &gt;-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.</non_inferiority_desc>
            <param_type>Rate difference (%)</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.26</ci_lower_limit>
            <ci_upper_limit>1.93</ci_upper_limit>
            <estimate_desc>The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI for the difference was &gt;-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.</non_inferiority_desc>
            <param_type>Rate difference (%)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.80</ci_lower_limit>
            <ci_upper_limit>-0.16</ci_upper_limit>
            <estimate_desc>The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12</title>
        <description>The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.</description>
        <time_frame>Weeks 4, 8 and 12</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12</title>
          <description>The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</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="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="95.67" upper_limit="100.00"/>
                    <measurement group_id="O2" value="99.3" lower_limit="98.03" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.2" lower_limit="91.80" upper_limit="98.68"/>
                    <measurement group_id="O2" value="99.3" lower_limit="98.03" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="92.72" upper_limit="99.12"/>
                    <measurement group_id="O2" value="98.7" lower_limit="96.83" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI for the difference was &gt;-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.</non_inferiority_desc>
            <param_type>Rate difference (%)</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.26</ci_lower_limit>
            <ci_upper_limit>1.93</ci_upper_limit>
            <estimate_desc>The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI for the difference was &gt;-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.</non_inferiority_desc>
            <param_type>Rate difference (%)</param_type>
            <param_value>-4.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.93</ci_lower_limit>
            <ci_upper_limit>-0.52</ci_upper_limit>
            <estimate_desc>The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Rate difference at Week 12. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI for the difference was &gt;-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.</non_inferiority_desc>
            <param_type>Rate difference (%)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.44</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12</title>
        <description>Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm). Lower scores indicated a better outcome. Baseline was defined as the last available assessment prior to the first dose of study medication. The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented.</description>
        <time_frame>Baseline (Day 1) and Weeks 4, 8 and 12</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12</title>
          <description>Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm). Lower scores indicated a better outcome. Baseline was defined as the last available assessment prior to the first dose of study medication. The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.4" lower_limit="-27.2" upper_limit="-21.6"/>
                    <measurement group_id="O2" value="-24.4" lower_limit="-27.1" upper_limit="-21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.5" lower_limit="-31.1" upper_limit="-25.9"/>
                    <measurement group_id="O2" value="-27.8" lower_limit="-30.3" upper_limit="-25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.1" lower_limit="-30.6" upper_limit="-25.7"/>
                    <measurement group_id="O2" value="-28.4" lower_limit="-30.8" upper_limit="-26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean E2 Concentration at Weeks Baseline and 4, 8 and 12</title>
        <description>The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
        <time_frame>Baseline (Day 1) and Weeks 4, 8 and 12</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean E2 Concentration at Weeks Baseline and 4, 8 and 12</title>
          <description>The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192.302" spread="258.209"/>
                    <measurement group_id="O2" value="218.893" spread="296.825"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.347" spread="46.253"/>
                    <measurement group_id="O2" value="18.959" spread="3.944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.175" spread="156.521"/>
                    <measurement group_id="O2" value="21.863" spread="12.550"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.600" spread="76.882"/>
                    <measurement group_id="O2" value="26.695" spread="31.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12</title>
        <description>The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
        <time_frame>Baseline (Day 1) and Weeks 4, 8 and 12</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12</title>
          <description>The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
          <units>International Units/L (IU/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.099" spread="3.929"/>
                    <measurement group_id="O2" value="6.258" spread="4.520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.762" spread="1.373"/>
                    <measurement group_id="O2" value="1.699" spread="1.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.891" spread="1.163"/>
                    <measurement group_id="O2" value="2.766" spread="1.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.344" spread="1.347"/>
                    <measurement group_id="O2" value="3.325" spread="1.414"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12</title>
        <description>The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
        <time_frame>Baseline and Weeks 4, 8 and 12</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12</title>
          <description>The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
          <units>IU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.376" spread="1.902"/>
                    <measurement group_id="O2" value="3.487" spread="1.858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.660" spread="1.771"/>
                    <measurement group_id="O2" value="0.500" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.444" spread="1.928"/>
                    <measurement group_id="O2" value="0.255" spread="0.122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.324" spread="0.555"/>
                    <measurement group_id="O2" value="0.251" spread="0.239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Menses Recovery</title>
        <description>Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period. Menses recovery status was assessed at all study visits from Day 1 to the end of study visit. The median time to menses recovery was analysed using the Kaplan-Meier method.</description>
        <time_frame>Baseline (Day 1) up to Week 40 (end of study visit)</time_frame>
        <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Triptorelin Pamoate PR 3-month</title>
            <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
          </group>
          <group group_id="O2">
            <title>Triptorelin Acetate PR 1-month</title>
            <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Menses Recovery</title>
          <description>Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period. Menses recovery status was assessed at all study visits from Day 1 to the end of study visit. The median time to menses recovery was analysed using the Kaplan-Meier method.</description>
          <population>The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.</population>
          <units>days</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="147"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.0" lower_limit="172.0" upper_limit="182.0"/>
                    <measurement group_id="O2" value="85.0" lower_limit="82.0" upper_limit="87.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).</time_frame>
      <desc>A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Triptorelin Pamoate PR 3-month</title>
          <description>Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).</description>
        </group>
        <group group_id="E2">
          <title>Triptorelin Acetate PR 1-month</title>
          <description>Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.1)</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="132" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="135" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="19" subjects_affected="13" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="149"/>
                <counts group_id="E2" events="30" subjects_affected="24" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="46" subjects_affected="37" subjects_at_risk="149"/>
                <counts group_id="E2" events="34" subjects_affected="27" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="150"/>
              </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="19" subjects_affected="12" subjects_at_risk="149"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="13" subjects_affected="9" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="149"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="79" subjects_affected="66" subjects_at_risk="149"/>
                <counts group_id="E2" events="82" subjects_affected="68" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="150"/>
              </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="10" subjects_affected="10" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="149"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="90" subjects_affected="86" subjects_at_risk="149"/>
                <counts group_id="E2" events="91" subjects_affected="89" subjects_at_risk="150"/>
              </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 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</name_or_title>
      <organization>Ipsen Pharma</organization>
      <phone>see email</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/NCT03232281
org study id: D-CN-52014-220
nct id: NCT03232281
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in
      Chinese female subjects with endometriosis by demonstrating the non-inferiority of
      triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate
      PR 1-month formulation injected 3 times consecutively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
time frame: Week 12
description: Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL).
The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.
measure: Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
time frame: Weeks 4 and 8
description: The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.
measure: Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
time frame: Weeks 4, 8 and 12
description: The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.
measure: Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
time frame: Baseline (Day 1) and Weeks 4, 8 and 12
description: Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm). Lower scores indicated a better outcome. Baseline was defined as the last available assessment prior to the first dose of study medication. The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented.
measure: Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
time frame: Baseline (Day 1) and Weeks 4, 8 and 12
description: The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.
measure: Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
time frame: Baseline (Day 1) and Weeks 4, 8 and 12
description: The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.
measure: Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
time frame: Baseline and Weeks 4, 8 and 12
description: The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.
measure: Median Time to Menses Recovery
time frame: Baseline (Day 1) up to Week 40 (end of study visit)
description: Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period. Menses recovery status was assessed at all study visits from Day 1 to the end of study visit. The median time to menses recovery was analysed using the Kaplan-Meier method.
arm group label: Triptorelin pamoate PR 3-month
arm group type: Experimental
description: Subjects received 15 mg triptorelin pamoate per injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
arm group label: Triptorelin acetate PR 1-month
arm group type: Active Comparator
description: Subjects received 3.75 mg triptorelin acetate per injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
intervention type: Drug
intervention name: Triptorelin Pamoate PR 3-month
description: 15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
arm group label: Triptorelin pamoate PR 3-month
other name: Triptorelin pamoate for injection 15 mg
intervention type: Drug
intervention name: Triptorelin Acetate PR 1-month
description: 3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
arm group label: Triptorelin acetate PR 1-month
other name: Diphereline 3.75 mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
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country: China
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Triptorelin Pamoate
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
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