<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/NCT03027648</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-OBGYN-2014</org_study_id>
    <nct_id>NCT03027648</nct_id>
  </id_info>
  <brief_title>Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis</brief_title>
  <official_title>Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To investigate the effects of levonorgestrel-releasing intrauterine system&#xD;
      (LNG-IUS) for symptomatic adenomyosis.&#xD;
&#xD;
      Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed&#xD;
      (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient&#xD;
      clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before&#xD;
      and after placement of LNG-IUS, during each following period, all the parameters were&#xD;
      recorded prospectively, including carrying status of IUS, symptoms and scores of&#xD;
      dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation&#xD;
      patterns and adverse effects.&#xD;
&#xD;
      Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea&#xD;
&#xD;
      Second outcome measures: carrying status of IUS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2006</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</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>improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system</measure>
    <time_frame>5 years after placement of levonorgestrel-releasing intrauterine system</time_frame>
    <description>visual analogue scale for pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system</measure>
    <time_frame>5 years after placement of levonorgestrel-releasing intrauterine system</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system</measure>
    <time_frame>5 years after placement of levonorgestrel-releasing intrauterine system</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improvement of symptoms of adenomyosis assessed by verbal rating scales for pain</measure>
    <time_frame>5 years after placement of levonorgestrel-releasing intrauterine system</time_frame>
    <description>verbal rating scales for pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea</measure>
    <time_frame>5 years after placement of levonorgestrel-releasing intrauterine system</time_frame>
    <description>hemoglobin for menorrhea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea</measure>
    <time_frame>5 years after placement of levonorgestrel-releasing intrauterine system</time_frame>
    <description>visual analogue scale for pain</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1100</enrollment>
  <condition>Adenomyosis</condition>
  <arm_group>
    <arm_group_label>patients with LNG-IUS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Placement of levonorgestrel-releasing intrauterine system</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placement of levonorgestrel-releasing intrauterine system</intervention_name>
    <description>All the patients accepted treatment of levonorgestrel-releasing intrauterine system</description>
    <arm_group_label>patients with LNG-IUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with regular menses&#xD;
&#xD;
          -  Adenomyosis diagnosed via transvaginal ultrasound&#xD;
&#xD;
          -  With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores &gt;100)&#xD;
&#xD;
          -  Duration of placement &gt; 12 months&#xD;
&#xD;
          -  Size of uterus by physical examination less than uterus of 12-week pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Desire for pregnancy or lactation&#xD;
&#xD;
          -  With diagnosis of malignancies or precancerous lesions&#xD;
&#xD;
          -  Acceptance of laparotomy&#xD;
&#xD;
          -  Contraindication of placing levonorgestrel-releasing intrauterine system&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leng Jinghua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>levonorgestrel-releasing intrauterine system</keyword>
  <keyword>adenomyosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenomyosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levonorgestrel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared with researchers via online database</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>January 21, 2017</submitted>
    <returned>March 9, 2017</returned>
  </pending_results>
  <!-- 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/NCT03027648
org study id: PUMCH-OBGYN-2014
nct id: NCT03027648
lead sponsor: 
has dmc: Yes
Objective: To investigate the effects of levonorgestrel-releasing intrauterine system
      (LNG-IUS) for symptomatic adenomyosis.

      Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed
      (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient
      clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before
      and after placement of LNG-IUS, during each following period, all the parameters were
      recorded prospectively, including carrying status of IUS, symptoms and scores of
      dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation
      patterns and adverse effects.

      Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea

      Second outcome measures: carrying status of IUS
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
description: visual analogue scale for pain
measure: unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system
time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
measure: spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system
time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
measure: improvement of symptoms of adenomyosis assessed by verbal rating scales for pain
time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
description: verbal rating scales for pain
measure: improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea
time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
description: hemoglobin for menorrhea
measure: improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea
time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
description: visual analogue scale for pain
arm group label: patients with LNG-IUS
arm group type: Other
description: Placement of levonorgestrel-releasing intrauterine system
intervention type: Procedure
intervention name: Placement of levonorgestrel-releasing intrauterine system
description: All the patients accepted treatment of levonorgestrel-releasing intrauterine system
arm group label: patients with LNG-IUS
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Leng Jinghua, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Associate Professor
mesh term: Adenomyosis
mesh term: Levonorgestrel
sharing ipd: Yes
ipd description: IPD will be shared with researchers via online database
submitted: January 21, 2017
returned: March 9, 2017