<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/NCT01695902</url>
  </required_header>
  <id_info>
    <org_study_id>2007-001564-77</org_study_id>
    <nct_id>NCT01695902</nct_id>
  </id_info>
  <brief_title>Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding</brief_title>
  <acronym>LVS-20</acronym>
  <official_title>A Multiple Center, Randomised, Parallel Group, Single-blind Clinical Trial, to Assess the Therapeutic Equivalence in Terms of Efficacy and Safety of Test Product (Levosert) and Reference Product (Mirena®) in Patients With Menorrhagia - Phase III (Therapeutic Equivalence).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uteron Pharma S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uteron Pharma S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study was to compare the efficacy of Test Product (Levosert)&#xD;
      vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood&#xD;
      loss volume in women with menorrhagia.&#xD;
&#xD;
      The secondary objectives includes physical and gynaecological examinations, vital signs,&#xD;
      clinical laboratory tests including hemoglobin and ferritin measurements, body weight and&#xD;
      spontaneously reported adverse events were analysed and compared between Levosert and Mirena®&#xD;
      treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various&#xD;
      periods of time. The residual amounts of LNG in the devices were finally measured after&#xD;
      withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were&#xD;
      compared between the two treatment groups. Contraceptive effect of Levosert was estimated by&#xD;
      Pearl Index.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2007</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">January 2010</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups</measure>
    <time_frame>up to three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the residual LNG level in the IUS in the 2 treatment groups</measure>
    <time_frame>up to three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline to year 1/year 3 in weight in the 2 treatment groups</measure>
    <time_frame>up to three years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups</measure>
    <time_frame>up to three years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups</measure>
    <time_frame>up to three years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence in the 2 treatment groups of evaluable untoward drug reactions</measure>
    <time_frame>up to three years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Contraception level and contraceptive effect in the 2 treatment groups</measure>
    <time_frame>up to three years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Heavy Menstrual Bleeding</condition>
  <arm_group>
    <arm_group_label>Levosert-20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Levosert is a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG in a cylindrical-shaped reservoir. The reservoir is mounted on the vertical arm of a T-shaped plastic frame and is covered with a release rate controlling membrane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirena®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levosert-20</intervention_name>
    <arm_group_label>Levosert-20</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirena</intervention_name>
    <arm_group_label>Mirena®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18&#xD;
             years of age.&#xD;
&#xD;
          -  Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.&#xD;
&#xD;
          -  Patients who are eligible and able to participate in the trial and who consent to do&#xD;
             so in writing after the purpose and nature of the investigation have been explained to&#xD;
             them.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of endometrial ablation or dilatation and/or curettage within the 3 months&#xD;
             prior to screening&#xD;
&#xD;
          -  Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Abnormal liver function or jaundice&#xD;
&#xD;
          -  Renal insufficiency&#xD;
&#xD;
          -  Other hormonal treatment (sexual steroids),&#xD;
&#xD;
          -  Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous&#xD;
             myomas of any size, or myometrial myomas &gt; than 3 cm, adenomyosis, atypical&#xD;
             hyperplasia, carcinoma)&#xD;
&#xD;
          -  Abnormal uterine morphology&#xD;
&#xD;
          -  Presence of ovarian cyst &gt; 3 cm&#xD;
&#xD;
          -  Lower genital tract infection&#xD;
&#xD;
          -  Current or recurrent PID (present or recurrent pelvis infection (including history of&#xD;
             postpartum endometritis, infected miscarriage) during the past 3 months&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Congenital or acquired valvular disease (including corrections with prosthetic valves)&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  Known or suspected hormone-dependent tumor&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Abnormal Pap smear test or other evidence of cervical/endometrial mancy&#xD;
&#xD;
          -  Unexplained amenorrhea&#xD;
&#xD;
          -  Known hypersensitivity to device material and/or Levonorgestrel&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2012</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>Menorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levonorgestrel</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01695902
org study id: 2007-001564-77
nct id: NCT01695902
lead sponsor: 
has dmc: No
The primary objective of this study was to compare the efficacy of Test Product (Levosert)
      vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood
      loss volume in women with menorrhagia.

      The secondary objectives includes physical and gynaecological examinations, vital signs,
      clinical laboratory tests including hemoglobin and ferritin measurements, body weight and
      spontaneously reported adverse events were analysed and compared between Levosert and Mirena®
      treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various
      periods of time. The residual amounts of LNG in the devices were finally measured after
      withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were
      compared between the two treatment groups. Contraceptive effect of Levosert was estimated by
      Pearl Index.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups
time frame: 1 year
measure: Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups
time frame: up to three years
measure: Comparison of the residual LNG level in the IUS in the 2 treatment groups
time frame: up to three years
measure: Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)
time frame: 1 year
measure: Change from baseline to year 1/year 3 in weight in the 2 treatment groups
time frame: up to three years
measure: Change from baseline to year 1 / year 3 in hemoglobin in the 2 treatment groups
time frame: up to three years
measure: Change from baseline to year 1/year 3 in ferritin in the 2 treatment groups
time frame: up to three years
measure: Occurrence in the 2 treatment groups of evaluable untoward drug reactions
time frame: up to three years
measure: Contraception level and contraceptive effect in the 2 treatment groups
time frame: up to three years
arm group label: Levosert-20
arm group type: Experimental
description: Levosert is a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG in a cylindrical-shaped reservoir. The reservoir is mounted on the vertical arm of a T-shaped plastic frame and is covered with a release rate controlling membrane.
arm group label: Mirena®
arm group type: Active Comparator
description: Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG.
intervention type: Drug
intervention name: Levosert-20
arm group label: Levosert-20
intervention type: Drug
intervention name: Mirena
arm group label: Mirena®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Menorrhagia
mesh term: Hemorrhage
mesh term: Levonorgestrel