<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/NCT01698164</url>
  </required_header>
  <id_info>
    <org_study_id>2008BAI57B04</org_study_id>
    <nct_id>NCT01698164</nct_id>
  </id_info>
  <brief_title>Multi-centre Clinical Trial on Hormone Replacement Treatment in China</brief_title>
  <official_title>Multi-centre Clinical Trial on Hormone Replacement Treatment in China</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>
  <brief_summary>
    <textblock>
      This study is to evaluate the benefit/risk of hormone replacement treatment among early&#xD;
      menopausal women in China. This is a multi-centre, random, prospective study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2008</start_date>
  <primary_completion_date type="Anticipated">October 2012</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months</measure>
    <time_frame>before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years</time_frame>
    <description>lipid profiles, high-sensitivity C-reactive protein, Hemoglobin A1C, fasting glucose, fasting insulin, blood pressure, waistline, hipline, body composition, electrocardiogram, incidence of coronary heart disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in risk factors of breast cancer at 12 months and 24 months</measure>
    <time_frame>before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years</time_frame>
    <description>Mammography, palpation of breast, incidence of breast cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in BMD at 12 months and 24 months</measure>
    <time_frame>before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years</time_frame>
    <description>DEXA bone mineral density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in risk factors of senile dementia every three months</measure>
    <time_frame>before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later</time_frame>
    <description>mini-mental state examination, hospital anxiety and depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the quality of life every three months</measure>
    <time_frame>before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later</time_frame>
    <description>Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in thickness of endometrium at 12 months and 24 months</measure>
    <time_frame>before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years</time_frame>
    <description>ultrasonography</description>
  </other_outcome>
  <other_outcome>
    <measure>uterine bleeding</measure>
    <time_frame>every three months after taking the medicine until two years later</time_frame>
    <description>diary</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in vital signs every three months</measure>
    <time_frame>before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later</time_frame>
    <description>height, weight, heart rate, BP, gynecological examination</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in general health at 12 months and 24 months</measure>
    <time_frame>before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years</time_frame>
    <description>liver function, renal function</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Menopausal Syndrome</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Osteoporosis</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>estradiol plus MPA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 4mg medroxyprogesterone acetate, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles.&#xD;
estradiol valerate, 1mg*21/box medroxyprogesterone acetate, 2mg*100/bottle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>estradiol plus progesterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 200mg progesterone capsule, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles.&#xD;
estradiol valerate, 1mg*21/box progesterone capsule, 100mg*6/box</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ximingting tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>estradiol plus MPA</intervention_name>
    <description>Participants are given estradiol and synthetic progestin.</description>
    <arm_group_label>estradiol plus MPA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ximingting Tablet</intervention_name>
    <description>Participants are given phytoestrogen.</description>
    <arm_group_label>Ximingting tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>estradiol plus progesterone</intervention_name>
    <description>Participants are given estradiol and natural progesterone.</description>
    <arm_group_label>estradiol plus progesterone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  going through amenorrhea above 6 months and within 5 years,&#xD;
&#xD;
          -  aged 40 to 60 years,&#xD;
&#xD;
          -  going though postmenopausal symptoms,&#xD;
&#xD;
          -  serum E2 concentration &lt;30pg/ml,&#xD;
&#xD;
          -  serum FSH concentration &gt;40IU/L.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uterine fibroid diameter≥5cm,&#xD;
&#xD;
          -  history of diabetes or hypertension,&#xD;
&#xD;
          -  history of thromboembolism, severe endometriosis, epilepsy, asthma,&#xD;
             hyperprolactinemia,&#xD;
&#xD;
          -  first degree relative had a history of breast cancer,&#xD;
&#xD;
          -  being in severe or unstable condition of somatic diseases,&#xD;
&#xD;
          -  receiving HRT in the past 3 month,&#xD;
&#xD;
          -  drug or alcohol abuse in the past 3 month,&#xD;
&#xD;
          -  endometrial thickness ≥0.5cm after withdrawal bleeding,&#xD;
&#xD;
          -  being allergic to the medicine,&#xD;
&#xD;
          -  participating in other clinical trials within 1 month ago.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aijun Sun, PH.D M.D</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tingping Zheng, Bachelor Degree</last_name>
    <email>zhengtingping@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>PUMCH</name>
      <address>
        <city>Peking</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Xue, Bachelor Degree</last_name>
      <email>xuewei8955@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <keyword>lipid profiles</keyword>
  <keyword>coronary heart disease</keyword>
  <keyword>menopausal syndrome</keyword>
  <keyword>MMSE</keyword>
  <keyword>MENQOL</keyword>
  <keyword>HAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
    <mesh_term>Progesterone</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/NCT01698164
org study id: 2008BAI57B04
nct id: NCT01698164
lead sponsor: 
This study is to evaluate the benefit/risk of hormone replacement treatment among early
      menopausal women in China. This is a multi-centre, random, prospective study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months
time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years
description: lipid profiles, high-sensitivity C-reactive protein, Hemoglobin A1C, fasting glucose, fasting insulin, blood pressure, waistline, hipline, body composition, electrocardiogram, incidence of coronary heart disease
measure: Change from Baseline in risk factors of breast cancer at 12 months and 24 months
time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
description: Mammography, palpation of breast, incidence of breast cancer
measure: Change from Baseline in BMD at 12 months and 24 months
time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
description: DEXA bone mineral density
measure: Change from Baseline in risk factors of senile dementia every three months
time frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
description: mini-mental state examination, hospital anxiety and depression scale
measure: Change from Baseline in the quality of life every three months
time frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
description: Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire
measure: Change from Baseline in thickness of endometrium at 12 months and 24 months
time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
description: ultrasonography
measure: uterine bleeding
time frame: every three months after taking the medicine until two years later
description: diary
measure: Change from Baseline in vital signs every three months
time frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
description: height, weight, heart rate, BP, gynecological examination
measure: Change from Baseline in general health at 12 months and 24 months
time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
description: liver function, renal function
arm group label: estradiol plus MPA
arm group type: Active Comparator
description: 1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 4mg medroxyprogesterone acetate, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles.
estradiol valerate, 1mg*21/box medroxyprogesterone acetate, 2mg*100/bottle
arm group label: estradiol plus progesterone
arm group type: Experimental
description: 1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 200mg progesterone capsule, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles.
estradiol valerate, 1mg*21/box progesterone capsule, 100mg*6/box
arm group label: Ximingting tablet
arm group type: Experimental
description: 1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years.
intervention type: Drug
intervention name: estradiol plus MPA
description: Participants are given estradiol and synthetic progestin.
arm group label: estradiol plus MPA
intervention type: Drug
intervention name: Ximingting Tablet
description: Participants are given phytoestrogen.
arm group label: Ximingting tablet
intervention type: Drug
intervention name: estradiol plus progesterone
description: Participants are given estradiol and natural progesterone.
arm group label: estradiol plus progesterone
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: Aijun Sun, PH.D M.D
role: Study Director
affiliation: Peking Union Medical College Hospital
last name: Tingping Zheng, Bachelor Degree
email: zhengtingping@gmail.com
facility: 
status: Recruiting
contact: 
country: China
mesh term: Osteoporosis
mesh term: Cardiovascular Diseases
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate
mesh term: Progesterone