<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/NCT03261999</url>
  </required_header>
  <id_info>
    <org_study_id>FP01C-17-001</org_study_id>
    <secondary_id>2017-001333-88</secondary_id>
    <nct_id>NCT03261999</nct_id>
  </id_info>
  <brief_title>Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer</brief_title>
  <official_title>An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foresee Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Foresee Pharmaceuticals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of&#xD;
      subjects with prostate cancer, when administered as two injections twelve weeks apart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-national, multi-center, open-label, single-arm study. All subjects will be&#xD;
      males with prostate cancer judged to be candidates for medical androgen ablation therapy and&#xD;
      all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 19, 2018</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>Efficacy of Leuprolide Mesylate (LMIS 25mg)</measure>
    <time_frame>168 days</time_frame>
    <description>The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>168 days</time_frame>
    <description>Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Leuprolide Mesylate 25mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.&#xD;
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide Mesylate</intervention_name>
    <description>Subcutaneous injection of 25mg Leuprolide Mesylate</description>
    <arm_group_label>Leuprolide Mesylate 25mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males aged ≥ 18 years old&#xD;
&#xD;
          2. Males with histologically confirmed carcinoma of the prostate&#xD;
&#xD;
          3. Subjects who are judged by the attending physician and/or Principal Investigator to be&#xD;
             a candidate for androgen ablation therapy&#xD;
&#xD;
          4. Baseline morning serum testosterone level &gt; 150 ng/dL performed at Screening Visit&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2&#xD;
&#xD;
          6. Life expectancy of at least 18 months&#xD;
&#xD;
          7. Laboratory values&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1,500 cells/µL&#xD;
&#xD;
               -  Platelets ≥ 100,000 cells/µL&#xD;
&#xD;
               -  Hemoglobin ≥ 10 gm/dL&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 × upper limit of normal (ULN)&#xD;
&#xD;
               -  AST (SGOT) ≤ 2.5 × ULN&#xD;
&#xD;
               -  ALT (SGPT) ≤ 2.5 × ULN&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 mg/dL&#xD;
&#xD;
               -  Lipid profile within acceptable range according to investigator's opinion&#xD;
&#xD;
               -  Serum glucose within acceptable range according to investigator's opinion&#xD;
&#xD;
               -  HgbA1c within acceptable range according to investigator's opinion&#xD;
&#xD;
               -  Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to&#xD;
                  investigator's judgment&#xD;
&#xD;
               -  Serum glucose within acceptable range according to investigator's judgement&#xD;
&#xD;
               -  Urinalysis within normal range according to the investigator's judgment&#xD;
&#xD;
          8. Agree to use male contraceptive methods during study trial&#xD;
&#xD;
          9. Based on the Investigator's judgment, the ability to understand the nature of the&#xD;
             study and any hazards of participation, and to communicate satisfactorily with the&#xD;
             Investigator and to participate in, and to comply with, the requirements of the entire&#xD;
             protocol&#xD;
&#xD;
         10. All aspects of the protocol explained and written informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen&#xD;
             therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of&#xD;
             carcinoma of the prostate. Radiation for pain control will be allowed during the&#xD;
             study.&#xD;
&#xD;
          2. Receipt of any vaccination (including influenza) within 4 weeks of screening visit&#xD;
&#xD;
          3. History of blood donation within 2 months of screening visit&#xD;
&#xD;
          4. History of anaphylaxis to any LH-RH analogues&#xD;
&#xD;
          5. Receipt of any LHRH suppressive therapy within 6 months of screening visit&#xD;
&#xD;
          6. Major surgery, including any prostatic surgery, within 4 weeks of screening visit&#xD;
&#xD;
          7. History and concomitant clinical and radiographic evidence of central nervous&#xD;
             system/spinal cord metastases and subjects at risk for spinal cord compression&#xD;
&#xD;
          8. Clinical evidence of active urinary tract obstruction and subjects at risk for urinary&#xD;
             obstruction&#xD;
&#xD;
          9. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy&#xD;
&#xD;
         10. History or presence of hypogonadism, or receipt of exogenous testosterone&#xD;
             supplementation within 6 months of Baseline&#xD;
&#xD;
         11. Clinically significant abnormal ECG and/or history of clinically significant&#xD;
             cardiovascular disease as judged by the investigator&#xD;
&#xD;
         12. History of drug and/or alcohol abuse within 6 months of Baseline&#xD;
&#xD;
         13. Contraindication to leuprolide or an LHRH agonist as indicated on package labeling&#xD;
&#xD;
         14. Use of 5-alpha reductase inhibitor within the last 6 months of screening visit&#xD;
&#xD;
         15. History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well&#xD;
             controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are&#xD;
             required. Prostate cancer subjects with poor controlled diabetes mellitus with Hb1Ac &gt;&#xD;
             9.5% or urine glycosuria &gt; 1.0 g/dL should be excluded.&#xD;
&#xD;
         16. Use of systemic corticosteroids at a dose &gt;10 mg/d or anti-androgens&#xD;
&#xD;
         17. Use of any investigational agent within 4 weeks of screening visit&#xD;
&#xD;
         18. Use of any over-the-counter (OTC) medication within 4 weeks of screening visit except&#xD;
             for those listed in the permitted Concomitant Treatment section.&#xD;
&#xD;
         19. Uncontrolled intercurrent illness that would jeopardize the subject's safety,&#xD;
             interfere with the objectives of the protocol, or limit the subject's compliance with&#xD;
             study requirements, as determined by the Investigator in consultation with the Sponsor&#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>John Mao, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Foresee Pharmaceuticals Co., Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Centers of Alabama</name>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Institute of Urology</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Urology Center of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Clinical Trials, LLC</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology San Antonio, P.A</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia, PLLC</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní nemocnice Hradec Králové, Urologická klinika</name>
      <address>
        <city>Hradec Králové</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uromedical Center Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice, Urologické oddělení</name>
      <address>
        <city>Praha</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41931</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hosptal</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>14068</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kauno klinikos</name>
      <address>
        <city>Kaunas</city>
        <zip>50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klaipėda University Hospital</name>
      <address>
        <city>Klaipėda</city>
        <zip>92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Vilnius</city>
        <zip>08660</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital, Santaros klinikos</name>
      <address>
        <city>Vilnius</city>
        <zip>08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UROCENTRUM MILAB, s.r.o.</name>
      <address>
        <city>Prešov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultná nemocnica s poliklinikou Žilina Urológia</name>
      <address>
        <city>Žilina</city>
        <zip>012 07</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Korea, Republic of</country>
    <country>Lithuania</country>
    <country>Slovakia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>March 16, 2020</results_first_submitted>
  <results_first_submitted_qc>April 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 4, 2020</results_first_posted>
  <last_update_submitted>April 30, 2020</last_update_submitted>
  <last_update_submitted_qc>April 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Neoplasm Cancer Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
  </intervention_browse>
  <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>November 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03261999/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 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03261999/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Leuprolide Mesylate 25mg</title>
          <description>Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.&#xD;
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ITT</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PP</title>
              <participants_list>
                <participants group_id="P1" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Leuprolide Mesylate 25mg</title>
          <description>Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.&#xD;
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="144"/>
          </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="69.8" spread="7.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lithuania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis (days) of prostate carcinoma history</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="842.7" spread="1348.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of Leuprolide Mesylate (LMIS 25mg)</title>
        <description>The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.</description>
        <time_frame>168 days</time_frame>
        <population>ITT (one subject had missing time point at Day 28)</population>
        <group_list>
          <group group_id="O1">
            <title>Leuprolide Mesylate 25mg</title>
            <description>Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.&#xD;
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Leuprolide Mesylate (LMIS 25mg)</title>
          <description>The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.</description>
          <population>ITT (one subject had missing time point at Day 28)</population>
          <units>Percentage of participants</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="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.9" lower_limit="93.5" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).</description>
        <time_frame>168 days</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Leuprolide Mesylate 25mg</title>
            <description>Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.&#xD;
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).</description>
          <population>Safety population</population>
          <units>subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>168 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Leuprolide Mesylate 25mg</title>
          <description>Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.&#xD;
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Non-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="144"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Oropharyngeal neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Rehabilitation therapy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Non-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="70" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>weight increased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hot flush</sub_title>
                <counts group_id="E1" events="35" subjects_affected="35" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="144"/>
              </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>All information from the trial is property of the Sponsor and the PI has no right on it except the prior writing authorization of the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Mao</name_or_title>
      <organization>Foresee Pharmaceuticals Co., Ltd</organization>
      <phone>+886 2-7750-0188</phone>
      <email>john.mao@foreseepharma.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/NCT03261999
org study id: FP01C-17-001
secondary id: 2017-001333-88
nct id: NCT03261999
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of
      subjects with prostate cancer, when administered as two injections twelve weeks apart.
This is a multi-national, multi-center, open-label, single-arm study. All subjects will be
      males with prostate cancer judged to be candidates for medical androgen ablation therapy and
      all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of Leuprolide Mesylate (LMIS 25mg)
time frame: 168 days
description: The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.
measure: Number of Participants With Adverse Events
time frame: 168 days
description: Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).
arm group label: Leuprolide Mesylate 25mg
arm group type: Experimental
description: All subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168.
intervention type: Drug
intervention name: Leuprolide Mesylate
description: Subcutaneous injection of 25mg Leuprolide Mesylate
arm group label: Leuprolide Mesylate 25mg
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Mao, PhD
role: Study Director
affiliation: Foresee Pharmaceuticals Co., Ltd.
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country: Czechia
country: Korea, Republic of
country: Lithuania
country: Slovakia
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Leuprolide
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 