<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/NCT03840993</url>
  </required_header>
  <id_info>
    <org_study_id>MT-2990-A01</org_study_id>
    <nct_id>NCT03840993</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of MT-2990 in Women With Endometriosis</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of MT-2990 in Women With Endometriosis Experiencing Endometrial Related Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma America Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma America Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of&#xD;
      moderate to severe endometriosis-related pain in women with surgically diagnosed&#xD;
      endometriosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">October 5, 2021</completion_date>
  <primary_completion_date type="Actual">May 13, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from Baseline to Week 16 in nonmenstrual pelvic pain using a pain scale ranges from 0 (none) to 3 (severe)</measure>
    <time_frame>Baseline to Week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from Baseline to Week 16 in dysmenorrhea using a pain scale ranges from 0 (none) to 3 (severe)</measure>
    <time_frame>Baseline to Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from Baseline to Week 16 in dyspareunia using a pain scale ranges from 0 (none) to 3 (severe)</measure>
    <time_frame>Baseline to Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Endometrial Related Pain</condition>
  <arm_group>
    <arm_group_label>MT-2990</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT-2990, IV, over 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, IV, over 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-2990</intervention_name>
    <description>IV</description>
    <arm_group_label>MT-2990</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IV</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent to participate in this study&#xD;
&#xD;
          -  Agree to approximately 30-90 day washout interval of hormonal therapies, if applicable&#xD;
&#xD;
          -  Have a history of regular menstrual cycles&#xD;
&#xD;
          -  Have a body mass index &lt; 45 kg/m^2 (inclusive)&#xD;
&#xD;
          -  Have documented surgical/laparoscopy diagnosis of endometriosis with 10 years&#xD;
&#xD;
          -  Agree to use 2 forms of nonhormonal contraception throughout the study&#xD;
&#xD;
          -  In the Investigator's opinion, subject is able to understand the nature of the study&#xD;
             and any risk involved in participation, and is willing to cooperate and comply with&#xD;
             the protocol restrictions and requirements including transvaginal ultrasound.&#xD;
&#xD;
          -  Have moderate to severe endometrial related pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant, breast feeding, or planning a pregnancy.&#xD;
&#xD;
          -  Subject is &lt; 6 months postpartum, postabortion, or post-pregnancy.&#xD;
&#xD;
          -  Willing to remove a hormonal intrauterine device (IUD) at least 30 days prior to&#xD;
             screening. (Non hormonal IUDs do not have to be removed)&#xD;
&#xD;
          -  AST, ALT, or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference&#xD;
             range&#xD;
&#xD;
          -  Have immunosuppression due to underlying medical condition&#xD;
&#xD;
          -  QTcF or QTcB ≥ 450 msec or clinically important abnormal findings on the ECG&#xD;
&#xD;
          -  Subject is not up-to-date on breast screening according to current guidelines.&#xD;
&#xD;
          -  Has a surgical history of hysterectomy, bilateral oophorectomy and any other recent&#xD;
             major surgery&#xD;
&#xD;
          -  Subject is required more than 2 weeks of continuous use of prohibited long-acting&#xD;
             narcotic or immediate release narcotic for treatment of endometriosis-associated pain.&#xD;
&#xD;
          -  Have chronic pelvic pain for nonendometriosis related causes, which require systemic&#xD;
             pharmaceutical chronic therapy for pain&#xD;
&#xD;
          -  Have other chronic pain syndrome which require chronic analgesic or other chronic&#xD;
             therapy&#xD;
&#xD;
          -  Have a clinically significant gynecologic condition identified on the TVU (e.g.,&#xD;
             complex ovarian cyst &gt; 3 cm or simple ovarian cyst &gt; 5 cm, clinically significant&#xD;
             endometrial pathology, single fibroid ≥ 4 cm or multiple (&gt; 4) fibroids that measure ≥&#xD;
             2 cm or symptomatic submucosal fibroid of any size&#xD;
&#xD;
          -  Have a current history of undiagnosed abnormal genital bleeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Head of Medical Science</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma America Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Precision Trials</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research Corporation</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ageless and Beautiful Medical Spa</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lundquist Institute at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Physiology Associates - Fort Myers</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AGA Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kendall South Medical Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altus Research</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axcess Medical Research</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Research Phase I-IV</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health and Life Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivetmar Medical Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Future Care Solution</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>American Research Centers of Florida</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agile Clinical Research Trials</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medi-Sense</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30363</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NuDirections Clinical Research</name>
      <address>
        <city>Dunwoody</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Studies America - Marietta</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Prime</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rosemark Women Care Specialists</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research - Idaho</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Advanced Gynecologic Surgery Institute</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GTC Research</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management - Covington Northshore Office</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Clinical Research Associates</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omni Fertility and Laser Institute</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71118</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Continental Clinical Solutions</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Saginaw Valley Medical Research Group/Women's OB-GYN</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Albuquerque Clinical Trials</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Carolina Women's Research and Wellness Clinic</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Unified Women's Clinical Research - Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>PMG Research of Rocky Mount</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Lyndhurst Gynecologic Associates</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Aventive Research - Colombus</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>North Star Medical Research</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>ClinEdge - Fusion Clinical Research of Spartanburg</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29301</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Precision Research Institute - Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77036</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
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  <location>
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      <name>Biopharma Informatic - Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Discovery Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Physician's Research Options (PRO)</name>
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        <city>Draper</city>
        <state>Utah</state>
        <zip>84020</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Physician's Research Options (PRO)</name>
      <address>
        <city>Pleasant Grove</city>
        <state>Utah</state>
        <zip>84062</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <disposition_first_submitted>April 27, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>April 27, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 3, 2022</disposition_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03840993
org study id: MT-2990-A01
nct id: NCT03840993
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of
      moderate to severe endometriosis-related pain in women with surgically diagnosed
      endometriosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change from Baseline to Week 16 in nonmenstrual pelvic pain using a pain scale ranges from 0 (none) to 3 (severe)
time frame: Baseline to Week 16
measure: Mean change from Baseline to Week 16 in dysmenorrhea using a pain scale ranges from 0 (none) to 3 (severe)
time frame: Baseline to Week 16
measure: Mean change from Baseline to Week 16 in dyspareunia using a pain scale ranges from 0 (none) to 3 (severe)
time frame: Baseline to Week 16
arm group label: MT-2990
arm group type: Experimental
description: MT-2990, IV, over 16 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, IV, over 16 weeks
intervention type: Drug
intervention name: MT-2990
description: IV
arm group label: MT-2990
intervention type: Drug
intervention name: Placebo
description: IV
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Head of Medical Science
role: Study Director
affiliation: Mitsubishi Tanabe Pharma America Inc.
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country: United States
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: Undecided