<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/NCT03778359</url>
  </required_header>
  <id_info>
    <org_study_id>2017-10-012AC</org_study_id>
    <nct_id>NCT03778359</nct_id>
  </id_info>
  <brief_title>Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis</brief_title>
  <official_title>Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Endometriosis (including adenomyosis) is one of the most common gynecological diseases among&#xD;
      women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow,&#xD;
      infertility, chronic lower abdominal pain, and painful intercourse. According to the&#xD;
      literature statistics, the prevalence of endometriosis in women of childbearing age is about&#xD;
      10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments&#xD;
      include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a&#xD;
      Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing&#xD;
      intrauterine system in the intrauterine administration system. The choice of drugs has many&#xD;
      influencing factors, such as the severity of endometriosis in patients (according to the&#xD;
      classification of the American Society for Reproductive Medicine), the need for fertility,&#xD;
      the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is&#xD;
      also one of the treatment options for endometriosis and adenomyosis, including traditional&#xD;
      open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion&#xD;
      resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or&#xD;
      minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and&#xD;
      cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment&#xD;
      consensus of obstetricians and gynecologists is to follow the surgical treatment of the&#xD;
      lesions and then follow-up medication. For women with adenomyosis, if they have completed the&#xD;
      birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The&#xD;
      possibility. However, for women who have not completed birth, conservative uterine&#xD;
      preservation surgery is performed. According to research statistics, endometriosis or&#xD;
      adenomyosis does not receive follow-up medical treatment after completion of surgical&#xD;
      treatment, there is a high probability of recurrence, but the side effects caused by drugs&#xD;
      will also affect the patient's compliance with medication.The Department of Women's Medicine&#xD;
      of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis.&#xD;
      Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study&#xD;
      was designed to analyze the differences in prognosis and recurrence of patients with&#xD;
      endometriosis and adenomyosis after receiving various surgical and medical treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose: to analyze the prognosis and treatment effect of endometriosis and&#xD;
      adenomyosis after surgery and drug treatment.&#xD;
&#xD;
      Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication,&#xD;
      the patient's assessment of drug side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2005</start_date>
  <completion_date type="Actual">October 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain before and after surgery</measure>
    <time_frame>01/2005~12/2015</time_frame>
    <description>Visual analogue scale ranges from 0 to 10 points, with higher scores indicative of more pain. We measure it before the surgery and follow it after intervention one month, three months and six months seperately.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>01/2005~12/2015</time_frame>
    <description>Preoperative serum hemoglobin levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately.&#xD;
The normal value is range 12-15g/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor marker (CA-125)</measure>
    <time_frame>01/2005~12/2015</time_frame>
    <description>Preoperative serum CA-125 levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately. The normal value is less than 35 U/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound image tracking</measure>
    <time_frame>01/2005~12/2015</time_frame>
    <description>Ovary endoemtriosis definition : Well-circumscribed thick-walled unilocular cyst that contains homogeneous low-level internal echoes ground glass. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group Adenomyosis definition : Asymmetrical myometrial thickening Globular shape, ill defined endometrial/ myometrial interface and linear striations. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvisin women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">5000</enrollment>
  <condition>Endometriosis</condition>
  <condition>Adenomyosis</condition>
  <arm_group>
    <arm_group_label>Gonadotropin-releasing hormone agonist treatment</arm_group_label>
    <description>Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrauterine device treatment</arm_group_label>
    <description>Endometriosis post-operative intrauterine device treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hormone therapy</arm_group_label>
    <description>Endometriosis post-operative hormone therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral contraceptive</arm_group_label>
    <description>Endometriosis post-operative oral contraceptive</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprorelin</intervention_name>
    <description>This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Leuprorelin.</description>
    <arm_group_label>Gonadotropin-releasing hormone agonist treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Levonorgestrel</intervention_name>
    <description>This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Levonorgestrel.</description>
    <arm_group_label>Intrauterine device treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dienogest</intervention_name>
    <description>This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Dienogest.</description>
    <arm_group_label>Hormone therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progestins</intervention_name>
    <description>This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Progestins.</description>
    <arm_group_label>Oral contraceptive</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects were patients who underwent endometriosis and adenomyosis-related surgery at&#xD;
        Taipei Veterans General Hospital from 2005 to 2018. Review the surgical records and related&#xD;
        medical records and record the follow-up medications received by the patients. The&#xD;
        procedure includes traditional open or endoscopic ovarian cyst resection, oophorectomy, and&#xD;
        lesion resection; open abdominal, transvaginal or endoscopic assisted transvaginal&#xD;
        hysterectomy, open or endoscopic adenoma, gland Myomectomy. Postoperative patients received&#xD;
        medication such as GnRH agonist, Levonorgestrel-releasing intrauterine system (LNG-IUS),&#xD;
        hormonal preparation (danazol, gestrinone, oral lutein), oral Oral contraceptive, and&#xD;
        tracking the size of the lesion with ultrasound, analyzing the patient's clinical&#xD;
        prognosis, pain, side effects and tolerance, follow-up pregnancy and production, the&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent endometriosis or adenomyosis-related surgery in the&#xD;
             investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up&#xD;
             medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Peng-Hui Wang, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>pongpongwang@gmail.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peng-Hui Wang</name>
      <address>
        <city>Taipei county</city>
        <state>Taipei</state>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</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>Endometriosis</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
    <mesh_term>Dienogest</mesh_term>
    <mesh_term>Levonorgestrel</mesh_term>
    <mesh_term>Progestins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03778359
org study id: 2017-10-012AC
nct id: NCT03778359
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Endometriosis (including adenomyosis) is one of the most common gynecological diseases among
      women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow,
      infertility, chronic lower abdominal pain, and painful intercourse. According to the
      literature statistics, the prevalence of endometriosis in women of childbearing age is about
      10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments
      include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a
      Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing
      intrauterine system in the intrauterine administration system. The choice of drugs has many
      influencing factors, such as the severity of endometriosis in patients (according to the
      classification of the American Society for Reproductive Medicine), the need for fertility,
      the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is
      also one of the treatment options for endometriosis and adenomyosis, including traditional
      open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion
      resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or
      minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and
      cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment
      consensus of obstetricians and gynecologists is to follow the surgical treatment of the
      lesions and then follow-up medication. For women with adenomyosis, if they have completed the
      birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The
      possibility. However, for women who have not completed birth, conservative uterine
      preservation surgery is performed. According to research statistics, endometriosis or
      adenomyosis does not receive follow-up medical treatment after completion of surgical
      treatment, there is a high probability of recurrence, but the side effects caused by drugs
      will also affect the patient's compliance with medication.The Department of Women's Medicine
      of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis.
      Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study
      was designed to analyze the differences in prognosis and recurrence of patients with
      endometriosis and adenomyosis after receiving various surgical and medical treatments.
The main purpose: to analyze the prognosis and treatment effect of endometriosis and
      adenomyosis after surgery and drug treatment.

      Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication,
      the patient's assessment of drug side effects.
observational model: Other
time perspective: Retrospective
measure: Pain before and after surgery
time frame: 01/2005~12/2015
description: Visual analogue scale ranges from 0 to 10 points, with higher scores indicative of more pain. We measure it before the surgery and follow it after intervention one month, three months and six months seperately.
measure: Hemoglobin
time frame: 01/2005~12/2015
description: Preoperative serum hemoglobin levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately.
The normal value is range 12-15g/dl.
measure: Tumor marker (CA-125)
time frame: 01/2005~12/2015
description: Preoperative serum CA-125 levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately. The normal value is less than 35 U/mL.
measure: Ultrasound image tracking
time frame: 01/2005~12/2015
description: Ovary endoemtriosis definition : Well-circumscribed thick-walled unilocular cyst that contains homogeneous low-level internal echoes ground glass. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group Adenomyosis definition : Asymmetrical myometrial thickening Globular shape, ill defined endometrial/ myometrial interface and linear striations. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvisin women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group
arm group label: Gonadotropin-releasing hormone agonist treatment
description: Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment
arm group label: Intrauterine device treatment
description: Endometriosis post-operative intrauterine device treatment
arm group label: Hormone therapy
description: Endometriosis post-operative hormone therapy
arm group label: Oral contraceptive
description: Endometriosis post-operative oral contraceptive
intervention type: Drug
intervention name: Leuprorelin
description: This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Leuprorelin.
arm group label: Gonadotropin-releasing hormone agonist treatment
intervention type: Device
intervention name: Levonorgestrel
description: This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Levonorgestrel.
arm group label: Intrauterine device treatment
intervention type: Drug
intervention name: Dienogest
description: This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Dienogest.
arm group label: Hormone therapy
intervention type: Drug
intervention name: Progestins
description: This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Progestins.
arm group label: Oral contraceptive
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Peng-Hui Wang, MD, PhD
role: Study Chair
affiliation: pongpongwang@gmail.com
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Adenomyosis
mesh term: Leuprolide
mesh term: Dienogest
mesh term: Levonorgestrel
mesh term: Progestins
sharing ipd: No