<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/NCT03264638</url>
  </required_header>
  <id_info>
    <org_study_id>PCOS201708</org_study_id>
    <nct_id>NCT03264638</nct_id>
  </id_info>
  <brief_title>A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS</brief_title>
  <official_title>A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of Polycystic Ovary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aijun Sun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the&#xD;
      combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in&#xD;
      adults women. One third of participants will receive Dingkundan capsules, one third of&#xD;
      participants will receive Diane-35 Pills, and the another third will receive Dingkundan&#xD;
      capsules and Diane-35 in combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We&#xD;
      generally treat PCOS patients without immediate fertility requirement by short-acting&#xD;
      contraceptives,Diane-35 is one of the most commonly used drugs.&#xD;
&#xD;
      Dingkundan consists of multiple chinese herbs including ginseng,Panax notoginseng,deer&#xD;
      antlers,Carthamus tinctorius L.,Radix Paeoniae Alba,prepared Radix Rehmanniae,Angelica etc.,&#xD;
      which gains widespread application in the treatment of gynecological diseases. Based on the&#xD;
      characteristics above, we try to explore its clinical application value in PCOS and its&#xD;
      biological mechanisms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>One third of participanta will receive Dingkun Dan Pills, one third of participanta will receive Diane-35 Pills, and the another third will receive Dingkun Dan pills and Diane-35 in combination.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>symptoms</measure>
    <time_frame>5 minutes</time_frame>
    <description>PCOS symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sex hormone levels changes</measure>
    <time_frame>5 minutes</time_frame>
    <description>sex hormone levels changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>lipid metabolism</measure>
    <time_frame>5 minutes</time_frame>
    <description>blood lipid profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolites figure spectrum</measure>
    <time_frame>5 minutes</time_frame>
    <description>metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin</measure>
    <time_frame>5 minutes</time_frame>
    <description>Fasting insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glycosylated hemoglobin</measure>
    <time_frame>5 minutes</time_frame>
    <description>glycosylated hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fasting blood glucose</measure>
    <time_frame>5 minutes</time_frame>
    <description>fasting blood glucose</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">315</enrollment>
  <condition>PCOS</condition>
  <arm_group>
    <arm_group_label>Dingkundan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dingkundan &amp; Diane-35</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diane-35</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dingkundan</intervention_name>
    <description>Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles</description>
    <arm_group_label>Dingkundan</arm_group_label>
    <other_name>A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dingkundan &amp; Diane-35</intervention_name>
    <description>Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles</description>
    <arm_group_label>Dingkundan &amp; Diane-35</arm_group_label>
    <other_name>A&amp;B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diane-35</intervention_name>
    <description>Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles</description>
    <arm_group_label>Diane-35</arm_group_label>
    <other_name>B</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is a female between the age of 18 and 40.&#xD;
&#xD;
          -  Subject diagnosed as PCOS by the 2003 Rotterdam criteria.&#xD;
&#xD;
          -  Subject provides written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has other endocrine diseases,such as adrenal hyperplasias or tumor,&#xD;
             androgen-secreting tumours, Cushing's syndrome,thyroid diseases and&#xD;
             hyperprolactinemia.&#xD;
&#xD;
          -  Subject has received related medical or surgical treatment in the past 3 months.&#xD;
&#xD;
          -  Subject suffered from substance abuse or dependence(such as alcohol or drugs);&#xD;
&#xD;
          -  Subject is a heavy smoker(reaching or more than 20 cigarettes a day).&#xD;
&#xD;
          -  Subject is pregnant or lactating or within 1 year after delivery.&#xD;
&#xD;
          -  Subject has a severe systemic disease, such as cardiovascular system&#xD;
&#xD;
          -  Subject has a history of malignancy or radiotherapy.&#xD;
&#xD;
          -  Subject has an allergic history to the drugs used in the study.&#xD;
&#xD;
          -  Subject has mental disorder incapable of elementary cooperations.&#xD;
&#xD;
          -  Subject has participated in other clinical researches of medicine within 3 month prior&#xD;
             to randomization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aijun Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, MD</last_name>
    <phone>139-1198-8831</phone>
    <phone_ext>+86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>China/Beiing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei L Li, MD</last_name>
      <phone>13911988831</phone>
      <phone_ext>+86</phone_ext>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://bestpractice.bmj.com/best-practice/monograph/141/treatment/guidelines.html</url>
    <description>treatment of polycystic ovary syndrome</description>
  </link>
  <link>
    <url>http://www.newhealthguide.org/Diane-Pills.html</url>
    <description>Diane can be used to ameliorate acne in PCOS patients</description>
  </link>
  <reference>
    <citation>Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.</citation>
    <PMID>14688154</PMID>
  </reference>
  <reference>
    <citation>Amiri M, Ramezani Tehrani F, Nahidi F, Kabir A, Azizi F, Carmina E. Effects of oral contraceptives on metabolic profile in women with polycystic ovary syndrome: A meta-analysis comparing products containing cyproterone acetate with third generation progestins. Metabolism. 2017 Aug;73:22-35. doi: 10.1016/j.metabol.2017.05.001. Epub 2017 May 10.</citation>
    <PMID>28732568</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Aijun Sun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>Dingkundan</keyword>
  <keyword>Diane-35</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyproterone Acetate</mesh_term>
    <mesh_term>Cyproterone</mesh_term>
    <mesh_term>Cyproterone acetate, ethinyl estradiol drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Network platform, and the website will be attached later.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within 2 months after the trial complete</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement</ipd_access_criteria>
  </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/NCT03264638
org study id: PCOS201708
nct id: NCT03264638
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the
      combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in
      adults women. One third of participants will receive Dingkundan capsules, one third of
      participants will receive Diane-35 Pills, and the another third will receive Dingkundan
      capsules and Diane-35 in combination.
Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We
      generally treat PCOS patients without immediate fertility requirement by short-acting
      contraceptives,Diane-35 is one of the most commonly used drugs.

      Dingkundan consists of multiple chinese herbs including ginseng,Panax notoginseng,deer
      antlers,Carthamus tinctorius L.,Radix Paeoniae Alba,prepared Radix Rehmanniae,Angelica etc.,
      which gains widespread application in the treatment of gynecological diseases. Based on the
      characteristics above, we try to explore its clinical application value in PCOS and its
      biological mechanisms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One third of participanta will receive Dingkun Dan Pills, one third of participanta will receive Diane-35 Pills, and the another third will receive Dingkun Dan pills and Diane-35 in combination.
primary purpose: Treatment
masking: None (Open Label)
measure: symptoms
time frame: 5 minutes
description: PCOS symptoms
measure: sex hormone levels changes
time frame: 5 minutes
description: sex hormone levels changes
measure: lipid metabolism
time frame: 5 minutes
description: blood lipid profile
measure: metabolites figure spectrum
time frame: 5 minutes
description: metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS
measure: Fasting insulin
time frame: 5 minutes
description: Fasting insulin
measure: glycosylated hemoglobin
time frame: 5 minutes
description: glycosylated hemoglobin
measure: fasting blood glucose
time frame: 5 minutes
description: fasting blood glucose
arm group label: Dingkundan
arm group type: Experimental
description: Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
arm group label: Dingkundan & Diane-35
arm group type: Experimental
description: Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
arm group label: Diane-35
arm group type: Active Comparator
description: Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
intervention type: Drug
intervention name: Dingkundan
description: Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
arm group label: Dingkundan
other name: A
intervention type: Drug
intervention name: Dingkundan & Diane-35
description: Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
arm group label: Dingkundan & Diane-35
other name: A&B
intervention type: Drug
intervention name: Diane-35
description: Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
arm group label: Diane-35
other name: B
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aijun Sun, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences
last name: Lei Li, MD
phone: 139-1198-8831
phone ext: +86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
url: http://bestpractice.bmj.com/best-practice/monograph/141/treatment/guidelines.html
description: treatment of polycystic ovary syndrome
url: http://www.newhealthguide.org/Diane-Pills.html
description: Diane can be used to ameliorate acne in PCOS patients
citation: Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
PMID: 14688154
citation: Amiri M, Ramezani Tehrani F, Nahidi F, Kabir A, Azizi F, Carmina E. Effects of oral contraceptives on metabolic profile in women with polycystic ovary syndrome: A meta-analysis comparing products containing cyproterone acetate with third generation progestins. Metabolism. 2017 Aug;73:22-35. doi: 10.1016/j.metabol.2017.05.001. Epub 2017 May 10.
PMID: 28732568
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Aijun Sun
investigator title: Principal Investigator
mesh term: Cyproterone Acetate
mesh term: Cyproterone
mesh term: Cyproterone acetate, ethinyl estradiol drug combination
sharing ipd: Yes
ipd description: Network platform, and the website will be attached later.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within 2 months after the trial complete
ipd access criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement