<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/NCT04428684</url>
  </required_header>
  <id_info>
    <org_study_id>Pepti 3.6 E 01</org_study_id>
    <nct_id>NCT04428684</nct_id>
  </id_info>
  <brief_title>COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg</brief_title>
  <official_title>COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg IN PATIENTS WITH DYSFUNCTIONAL UTERINE BLEEDING REQUIRING ENDOMETRIAL ABLATION.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peptigroupe Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peptigroupe Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The comparator drug (Zoladex 3.6 mg) is approved for use as a thinning agent for the&#xD;
      endometrium prior to endometrial ablation. The dosing recommendation is one or two depots&#xD;
      with each depot given four weeks apart. When two depots are administered, surgery should be&#xD;
      performed within two to four weeks following administration of the second depot.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to demonstrate non-inferiority of a generic formulation&#xD;
      of goserelin 3.6 mg as compared to Zoladex ® 3.6 mg on endometrial thinning prior to surgery.&#xD;
      The study is an open label, multicenter, prospective, parallel group randomized study.&#xD;
&#xD;
      Blind for Sponsor, ultrasound assessment, testing labs and statistician, the study will be&#xD;
      performed in premenopausal women with dysfunctional uterine bleeding (DUB) eligible for&#xD;
      endometrial ablation. Patients will be randomized in a 1 to 1 ratio to receive either the&#xD;
      Peptigroupe test product (Pepti 3.6 mg) or Zoladex® 3.6 mg for a treatment of 8 weeks (two&#xD;
      injections).&#xD;
&#xD;
      Ultrasonic measurement of endometrial thickness will be performed on screening and on days 0&#xD;
      (pre-injection), 28 (pre-injection) and 42 (pre surgical procedure).&#xD;
&#xD;
      The pharmacodynamics profile will be tabulated at the end of the study on the basis of the&#xD;
      following data:&#xD;
&#xD;
        1. Estradiol&#xD;
&#xD;
        2. LH and FSH as additional information on hormone response&#xD;
&#xD;
      Goserelin safety profile will be assessed throughout the study on the basis of the following&#xD;
      assessments:&#xD;
&#xD;
        1. Treatment-emergent AEs&#xD;
&#xD;
        2. Physical examinations&#xD;
&#xD;
        3. Vital signs&#xD;
&#xD;
        4. 12-Lead ECG&#xD;
&#xD;
        5. Laboratory parameters (i.e., biochemistry, haematology, and urinalysis)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Actual">June 7, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Comparative parallel design aimed at showing non-inferiority</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Sponsor, independant statistician, radiologists and bioanalytical lab are all blinded to treatment regimen</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Non-inferiority in terms of activity of test drug versus comparator</measure>
    <time_frame>1 year</time_frame>
    <description>Non-inferiority of test drug compared to comparator in terms of reduction of the endometrial thickness prior to surgical ablation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Dysfunctional Uterine Bleeding</condition>
  <arm_group>
    <arm_group_label>Pepti 3.6 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zoladex 3.6 mg treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pepti 3.6 mg</intervention_name>
    <description>Each patient receives one injection of Pepti 3.6mg or Zoladex 3.6mg on Day 0 and a second injection of the same drug given the first time on Day 28. On Day 42 patients undergo endometrial ablation</description>
    <arm_group_label>Pepti 3.6 treatment</arm_group_label>
    <arm_group_label>Zoladex 3.6 mg treatment</arm_group_label>
    <other_name>Zoladex 3.6 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Be pre-Menopausal females with regular menstrual cycles and &gt; 30 years of age 2.&#xD;
        Premenopausal at enrollment as determined by FSH measurement ≤ 60 IU/mL. 3. Endometrial&#xD;
        thickness at pre-treatment less than 20 mm. 4. Diagnosis of Dysfunctional Uterine Bleeding&#xD;
        and requiring endometrial ablation 5. Tumour negative cytology and histology 6. Appropriate&#xD;
        sized uterus with no anatomic pathologies 7. Patient is not pregnant and does not wish to&#xD;
        become pregnant in the future 8. Patient is willing to use a non-hormonal contraception&#xD;
        method during the study, nor an intra-uterine device 9. Patient has no endocrine disorders,&#xD;
        is not receiving hormonal therapies or non-steroidal anti-inflammatory medication.&#xD;
        (prophylactic antibiotics can be administered according to the usual practice of the&#xD;
        investigator) 10. Have the ability to understand the requirements of the study and is&#xD;
        willing to provide written informed consent 11. Agree to abide by the study restrictions&#xD;
        and return for the required assessments 12. Only patients which can be discontinued safely&#xD;
        from contra-indicated medications discussed below in section 7.4 can be included in the&#xD;
        study.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Be pregnant or have desire to conceive&#xD;
&#xD;
          2. Have abnormal endometrial cytology as confirmed by histology&#xD;
&#xD;
          3. Have active endometritis&#xD;
&#xD;
          4. Have active pelvic inflammatory disease&#xD;
&#xD;
          5. Have active sexually transmitted disease (STD), at the time of ablation. Note:&#xD;
             Treatment of STD documented in the chart serves as sufficient evidence of infection&#xD;
             resolution. Patient may be considered for study enrollment.&#xD;
&#xD;
          6. Presence of bacteremia, sepsis, or other active systemic infection&#xD;
&#xD;
          7. Have active infection of the genitals, vagina, cervix, uterus or urinary tract at the&#xD;
             time of inclusion&#xD;
&#xD;
          8. Known/suspected gynecological malignancy within the past 5 years&#xD;
&#xD;
          9. Known clotting defects or bleeding disorders&#xD;
&#xD;
         10. Untreated/unevaluated cervical dysplasia&#xD;
&#xD;
         11. Known/suspected abdominal/pelvic cancer&#xD;
&#xD;
         12. Atypical Hyperplasia&#xD;
&#xD;
         13. Prior uterine surgery (except low segment cesarean section) that interrupts the&#xD;
             integrity of the uterine wall (e.g., myomectomy or classical cesarean section&#xD;
&#xD;
         14. Currently on medications that could thin the myometrial muscle, such as long-term&#xD;
             steroid use (except inhaler or nasal therapy for asthma)&#xD;
&#xD;
         15. Currently on anticoagulants&#xD;
&#xD;
         16. Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists,&#xD;
             any LHRH agonists (e.g., leuprolide (Lupron®), goserelin ( Zoladex®) etc.) or to the&#xD;
             PLGA polymers contained in the study formulation&#xD;
&#xD;
         17. Have a severe liver disease (e.g., cirrhosis, chronic active hepatitis or chronic&#xD;
             persistent hepatitis) or has persistent ALT, AST ˃ 2 X ULN, serum creatinine ˃ 2 X&#xD;
             ULN, serum bilirubin ˃ 2 X ULN&#xD;
&#xD;
         18. Have received an investigational drug or participated in a clinical trial within the&#xD;
             last 30 days&#xD;
&#xD;
         19. Have clinically serious and/or unstable concurrent infection, medical illnesses or&#xD;
             conditions that are uncontrolled or whose control, in the opinion of the Investigator,&#xD;
             may be jeopardized by participation in this study or by the complications of this&#xD;
             therapy&#xD;
&#xD;
         20. Patients with BMI ˂ 18&#xD;
&#xD;
         21. Anticoagulated patients with INR ≥ 2&#xD;
&#xD;
         22. Patients with a history of QT prolongation, congenital long QT syndrome, electrolyte&#xD;
             abnormalities, CHF, or concurrent administration with QT prolonging drugs or QTc ˃450&#xD;
             msec.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonabes deRougé, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peptigroupe Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrii Zaremba</last_name>
    <role>Study Chair</role>
    <affiliation>Pharmaxi LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Military Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>01133</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Center</name>
      <address>
        <city>Kyiv</city>
        <zip>03039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternity Hospital no 3</name>
      <address>
        <city>Kyiv</city>
        <zip>03148</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Innovative Medical Technologies of the National Academy of Sciences</name>
      <address>
        <city>Kyiv</city>
        <zip>04053</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>04112</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Hemorrhage</mesh_term>
    <mesh_term>Metrorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Goserelin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD with other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04428684
org study id: Pepti 3.6 E 01
nct id: NCT04428684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The comparator drug (Zoladex 3.6 mg) is approved for use as a thinning agent for the
      endometrium prior to endometrial ablation. The dosing recommendation is one or two depots
      with each depot given four weeks apart. When two depots are administered, surgery should be
      performed within two to four weeks following administration of the second depot.
The primary objective of the study is to demonstrate non-inferiority of a generic formulation
      of goserelin 3.6 mg as compared to Zoladex ® 3.6 mg on endometrial thinning prior to surgery.
      The study is an open label, multicenter, prospective, parallel group randomized study.

      Blind for Sponsor, ultrasound assessment, testing labs and statistician, the study will be
      performed in premenopausal women with dysfunctional uterine bleeding (DUB) eligible for
      endometrial ablation. Patients will be randomized in a 1 to 1 ratio to receive either the
      Peptigroupe test product (Pepti 3.6 mg) or Zoladex® 3.6 mg for a treatment of 8 weeks (two
      injections).

      Ultrasonic measurement of endometrial thickness will be performed on screening and on days 0
      (pre-injection), 28 (pre-injection) and 42 (pre surgical procedure).

      The pharmacodynamics profile will be tabulated at the end of the study on the basis of the
      following data:

        1. Estradiol

        2. LH and FSH as additional information on hormone response

      Goserelin safety profile will be assessed throughout the study on the basis of the following
      assessments:

        1. Treatment-emergent AEs

        2. Physical examinations

        3. Vital signs

        4. 12-Lead ECG

        5. Laboratory parameters (i.e., biochemistry, haematology, and urinalysis)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparative parallel design aimed at showing non-inferiority
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Sponsor, independant statistician, radiologists and bioanalytical lab are all blinded to treatment regimen
measure: Non-inferiority in terms of activity of test drug versus comparator
time frame: 1 year
description: Non-inferiority of test drug compared to comparator in terms of reduction of the endometrial thickness prior to surgical ablation
arm group label: Pepti 3.6 treatment
arm group type: Experimental
description: Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
arm group label: Zoladex 3.6 mg treatment
arm group type: Active Comparator
description: Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
intervention type: Drug
intervention name: Pepti 3.6 mg
description: Each patient receives one injection of Pepti 3.6mg or Zoladex 3.6mg on Day 0 and a second injection of the same drug given the first time on Day 28. On Day 42 patients undergo endometrial ablation
arm group label: Pepti 3.6 treatment
arm group label: Zoladex 3.6 mg treatment
other name: Zoladex 3.6 mg
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bonabes deRougé, MD
role: Study Director
affiliation: Peptigroupe Inc.
last name: Andrii Zaremba
role: Study Chair
affiliation: Pharmaxi LLC
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ukraine
responsible party type: Sponsor
mesh term: Uterine Hemorrhage
mesh term: Metrorrhagia
mesh term: Hemorrhage
mesh term: Goserelin
sharing ipd: No
ipd description: There is no plan to share IPD with other researchers