<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/NCT03790215</url>
  </required_header>
  <id_info>
    <org_study_id>EP-1</org_study_id>
    <nct_id>NCT03790215</nct_id>
  </id_info>
  <brief_title>Dydrogesterone in the Treatment of Endometrial Polyps</brief_title>
  <official_title>Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to observe the therapeutic effect of dydrogesterone on endometrial&#xD;
      polyps and provide a reference for clinical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure&#xD;
      of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that&#xD;
      the progesterone can accelerate the regression rate of endometrial polyps due to its&#xD;
      antiestrogenic effects.Based on this, investigators intended to observe the therapeutic&#xD;
      effect of dydrogesterone on endometrial polyps and provide a reference for clinical&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>Phase 4</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>Regression rate of endometrial polyps</measure>
    <time_frame>three months after the starting of treatment</time_frame>
    <description>No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relapse rate of endometrial polyps</measure>
    <time_frame>six months after the starting of treatment</time_frame>
    <description>Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>three months after the starting of treatment</time_frame>
    <description>Any side effects during the treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Endometrial Polyp</condition>
  <arm_group>
    <arm_group_label>cohort for treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants enrolled are given dydrogesterone tablet of 10mg twice a day, from day 15 to day 24 of the menstrual cycle over a period of 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dydrogesterone</intervention_name>
    <description>The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.</description>
    <arm_group_label>cohort for treatment</arm_group_label>
    <other_name>Duphaston</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. women of childbearing age from 20 to 50 years old&#xD;
&#xD;
          2. with or without menstrual changes:&#xD;
&#xD;
               1. menostaxis (longer than 7 days)&#xD;
&#xD;
               2. shortened menstrual cycles(less than 23 days)&#xD;
&#xD;
               3. menorrhagia(more than twice as much as usual)&#xD;
&#xD;
               4. abnormal vaginal bleeding(non-menstrual vaginal bleeding)&#xD;
&#xD;
          3. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of&#xD;
             a menstrual cycle):&#xD;
&#xD;
               1. typical signs with a suspect of EP: (median/high) echo with a regular contour&#xD;
                  within the uterine lumen;&#xD;
&#xD;
               2. atypical signs with a suspect of EP: punctate cystic areas within the endometrium&#xD;
                  and the endometrial thickness &gt;1cm;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. no menses within half a year;&#xD;
&#xD;
          2. surgery or drug treatment of endometrial lesions in the past half year;&#xD;
&#xD;
          3. with current intrauterine device;&#xD;
&#xD;
          4. combined with other acute gynecological inflammation;&#xD;
&#xD;
          5. with clinically suspected malignant tumors;&#xD;
&#xD;
          6. long-term use of oral contraceptives;&#xD;
&#xD;
          7. with abnormal liver and kidney function;&#xD;
&#xD;
          8. with benign or malignant breast tumors;&#xD;
&#xD;
          9. with any systemic malignant tumor or a history of tumors;&#xD;
&#xD;
         10. participants who are pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>January 19, 2020</last_update_submitted>
  <last_update_submitted_qc>January 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</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>shuwang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Neoplasms</mesh_term>
    <mesh_term>Polyps</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dydrogesterone</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/NCT03790215
org study id: EP-1
nct id: NCT03790215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is intended to observe the therapeutic effect of dydrogesterone on endometrial
      polyps and provide a reference for clinical treatment.
Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure
      of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that
      the progesterone can accelerate the regression rate of endometrial polyps due to its
      antiestrogenic effects.Based on this, investigators intended to observe the therapeutic
      effect of dydrogesterone on endometrial polyps and provide a reference for clinical
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Regression rate of endometrial polyps
time frame: three months after the starting of treatment
description: No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound
measure: Relapse rate of endometrial polyps
time frame: six months after the starting of treatment
description: Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment
measure: Side effects
time frame: three months after the starting of treatment
description: Any side effects during the treatment
arm group label: cohort for treatment
arm group type: Experimental
description: Participants enrolled are given dydrogesterone tablet of 10mg twice a day, from day 15 to day 24 of the menstrual cycle over a period of 3 months.
intervention type: Drug
intervention name: Dydrogesterone
description: The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.
arm group label: cohort for treatment
other name: Duphaston
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: shuwang
investigator title: Associate Professor
mesh term: Uterine Neoplasms
mesh term: Polyps
mesh term: Dydrogesterone