<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/NCT02234115</url>
  </required_header>
  <id_info>
    <org_study_id>FP01C-13-001</org_study_id>
    <secondary_id>2013-001790-25</secondary_id>
    <nct_id>NCT02234115</nct_id>
  </id_info>
  <brief_title>Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma</brief_title>
  <official_title>An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of&#xD;
      subjects with advanced prostate carcinoma, when administered as two injections six months&#xD;
      apart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was&#xD;
      established to provide a vanguard of the first 30 subjects who will have more frequent&#xD;
      monitoring of their safety. If safety is established, the remainder of the subjects will be&#xD;
      entered into the clinical study (i.e., Part II). All subjects will be males with advanced&#xD;
      prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all&#xD;
      will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 5, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2016</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 50mg)</measure>
    <time_frame>baseline to 28 days, 28 days to 336 days</time_frame>
    <description>The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>336 days</time_frame>
    <description>Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Leuprolide Mesylate 50mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide Mesylate</intervention_name>
    <description>Subcutaneous injection of 50mg Leuprolide Mesylate</description>
    <arm_group_label>Leuprolide Mesylate 50mg</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 judgment&#xD;
&#xD;
               -  HgbA1c within acceptable range according to investigator's judgment&#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;
          -  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;
          -  Receipt of any vaccination (including influenza) within 4 weeks of Baseline&#xD;
&#xD;
          -  History of blood donation within 2 months of Baseline&#xD;
&#xD;
          -  History of anaphylaxis to any LH-RH analogues&#xD;
&#xD;
          -  Receipt of any LHRH suppressive therapy within 6 months of Baseline&#xD;
&#xD;
          -  Major surgery, including any prostatic surgery, within 4 weeks of Baseline&#xD;
&#xD;
          -  History and concomitant clinical and radiographic evidence of central nervous&#xD;
             system/spinal cord metastases. Subjects at risk for spinal cord compression will be&#xD;
             excluded.&#xD;
&#xD;
          -  Clinical evidence of active urinary tract obstruction and subjects at risk for urinary&#xD;
             obstruction&#xD;
&#xD;
          -  History of bilateral orchiectomy, adrenalectomy, or hypophysectomy&#xD;
&#xD;
          -  History or presence of hypogonadism, or receipt of exogenous testosterone&#xD;
             supplementation within 6 months of Baseline&#xD;
&#xD;
          -  Clinically significant abnormal ECG and/or history of clinically significant&#xD;
             cardiovascular disease as judged by the investigator&#xD;
&#xD;
          -  History of drug and/or alcohol abuse within 6 months of Baseline&#xD;
&#xD;
          -  Contraindication to leuprolide or an LHRH agonist as indicated on package labeling&#xD;
&#xD;
          -  Use of 5-alpha reductase inhibitor within the last 6 months of Baseline&#xD;
&#xD;
          -  History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well&#xD;
             controlled diabetes mellitus Type II will be allowed&#xD;
&#xD;
          -  Use of systemic corticosteroids at a dose &gt;10 mg/d or anti-androgens&#xD;
&#xD;
          -  Use of any investigational agent within 4 weeks of Baseline&#xD;
&#xD;
          -  Use of any over-the-counter (OTC) medication within 4 weeks of Baseline except for&#xD;
             those listed in the permitted Concomitant Treatment section.&#xD;
&#xD;
          -  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>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Research, LLC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institute - Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdvanceMed Research</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</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>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Urology Research Center</name>
      <address>
        <city>Burien</city>
        <state>Washington</state>
        <zip>98166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH Linz GmbH, Department of Urology</name>
      <address>
        <city>Linz</city>
        <state>Oberösterreich</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice Urologické oddělení</name>
      <address>
        <city>Praha</city>
        <state>Praha 4 - Krč</state>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Hradec Králové</name>
      <address>
        <city>Hradec Králové</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum RWTH Aachen, Klinik für Urologie</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PI 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>PI Klaipėda University Hospital</name>
      <address>
        <city>Klaipėda</city>
        <zip>92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PI Vilnius University Hospital, Santariškių Klinikos</name>
      <address>
        <city>Vilnius</city>
        <zip>08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne, Klinika Urologii</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-402</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej</name>
      <address>
        <city>Warzawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego</name>
      <address>
        <city>Warzawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;DERMED&quot; Centrum Medyczne Sp. z o.o.</name>
      <address>
        <city>Łódź</city>
        <zip>90-265</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UROCENTRUM MILAB, s.r.o.</name>
      <address>
        <city>Prešov</city>
        <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>
    <facility>
      <name>Kaohsiung Veteran General Hospital (VGHKS)</name>
      <address>
        <city>Kaohsiung City</city>
        <state>Pingtung</state>
        <zip>813</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital (CMUH)</name>
      <address>
        <city>Taichung City</city>
        <state>Taichung</state>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veteran General Hospital (VGHTC)</name>
      <address>
        <city>Taichung City</city>
        <state>Taichung</state>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital (NCKUH)</name>
      <address>
        <city>Tainan City</city>
        <state>Tainan</state>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital (NTUH)</name>
      <address>
        <city>Taipei City</city>
        <state>Taipei</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, LinKou (CGMH-LK)</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Lithuania</country>
    <country>Poland</country>
    <country>Slovakia</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>February 13, 2018</results_first_submitted>
  <results_first_submitted_qc>March 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2018</results_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</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>Carcinoma</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Leuprolide Mesylate 50mg</title>
          <description>All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 50mg 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="137"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ITT</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PP</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PK Subgroup</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
              </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 50mg</title>
          <description>All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="137"/>
          </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="71.1" spread="8.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </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="5"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                  </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="1"/>
                  </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>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lithuania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of Leuprolide Mesylate (LMIS 50mg)</title>
        <description>The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).</description>
        <time_frame>baseline to 28 days, 28 days to 336 days</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Leuprolide Mesylate 50mg</title>
            <description>All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Leuprolide Mesylate (LMIS 50mg)</title>
          <description>The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).</description>
          <population>ITT</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" lower_limit="92.2" upper_limit="98.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.</description>
        <time_frame>336 days</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Leuprolide Mesylate 50mg</title>
            <description>All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.</description>
          <population>Safety population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>336 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Leuprolide Mesylate 50mg</title>
          <description>All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.&#xD;
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</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="3" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </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="137"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</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="114" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="137"/>
              </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="12" subjects_affected="9" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="18" subjects_affected="13" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="137"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="69" subjects_affected="67" subjects_at_risk="137"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="23" subjects_affected="20" subjects_at_risk="137"/>
              </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>Dr. John Mao</name_or_title>
      <organization>Foresee Pharmaceuticals co., Ltd.</organization>
      <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/NCT02234115
org study id: FP01C-13-001
secondary id: 2013-001790-25
nct id: NCT02234115
lead sponsor: 
has dmc: Yes
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of
      subjects with advanced prostate carcinoma, when administered as two injections six months
      apart.
This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was
      established to provide a vanguard of the first 30 subjects who will have more frequent
      monitoring of their safety. If safety is established, the remainder of the subjects will be
      entered into the clinical study (i.e., Part II). All subjects will be males with advanced
      prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all
      will receive two injections of LMIS 50 mg six-month 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 50mg)
time frame: baseline to 28 days, 28 days to 336 days
description: The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
measure: Number of Participants With Adverse Events (AEs)
time frame: 336 days
description: Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.
arm group label: Leuprolide Mesylate 50mg
arm group type: Experimental
description: All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.
intervention type: Drug
intervention name: Leuprolide Mesylate
description: Subcutaneous injection of 50mg Leuprolide Mesylate
arm group label: Leuprolide Mesylate 50mg
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: Austria
country: Czechia
country: Germany
country: Lithuania
country: Poland
country: Slovakia
country: Taiwan
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Prostatic Neoplasms
mesh term: Leuprolide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 