<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/NCT04495855</url>
  </required_header>
  <id_info>
    <org_study_id>21088</org_study_id>
    <nct_id>NCT04495855</nct_id>
  </id_info>
  <brief_title>A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants</brief_title>
  <acronym>VISANNE OS</acronym>
  <official_title>VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      Endometriosis is a condition that affects women, usually during their reproductive years. In&#xD;
      women with endometriosis, the tissue that lines the uterus starts to grow outside of the&#xD;
      uterus. This can cause pain during their periods or during sex, and constant pain in the&#xD;
      pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment&#xD;
      to control the symptoms.&#xD;
&#xD;
      For some women with endometriosis, symptoms can return after they stop treatment. Or, they&#xD;
      may not be able to tolerate the current long-term treatment options.&#xD;
&#xD;
      In this study, researchers will find out more about the safety of long-term treatment with&#xD;
      dienogest in a large number of Chinese participants. This study will enroll patients from&#xD;
      post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the&#xD;
      participants will take dienogest based on their doctor's instructions. They will then visit&#xD;
      their doctor's office 3 times over 6 months. During these visits, their doctors will ask them&#xD;
      if they have any health problems and about their quality of life. Their doctors will also do&#xD;
      tests to measure the pain caused by their endometriosis and any other symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Actual">December 23, 2022</completion_date>
  <primary_completion_date type="Actual">December 23, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The absolute number of AEs reported with Visanne treatment</measure>
    <time_frame>From baseline up to 6 months</time_frame>
    <description>AE: Adverse Event</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The absolute number of ADRs reported with Visanne treatment</measure>
    <time_frame>From baseline up to 6 months</time_frame>
    <description>ADR: Adverse drug reaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of AEs reported with Visanne treatment</measure>
    <time_frame>From baseline up to 6 months</time_frame>
    <description>Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of ADRs reported with Visanne treatment</measure>
    <time_frame>From baseline up to 6 months</time_frame>
    <description>Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment</measure>
    <time_frame>From baseline up to 1,3,6 months</time_frame>
    <description>NRS: 0-10 integers.&quot;absence of pain&quot; corresponds to the value of &quot;0&quot; and unbearable pain corresponding to the value of &quot;10&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment</measure>
    <time_frame>At baseline and 6 months.</time_frame>
    <description>EHP-5 contains 11 questions (items): five items including pain, control and powerlessness, emotional well-being, lack of social support, self image from the core questionnaire and six items from the modular questionnaire that may not be applicable to every woman with endometriosis including work, intercourse, and worries about infertility, treatment, and relationship with children and medical professionals. Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and physician's satisfaction score on Visanne® treatment</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Global Impression (CGI) scale scores of overall symptom development</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for discontinuation of using Visanne</measure>
    <time_frame>From baseline up to 6 months</time_frame>
    <description>Discontinuation reasons identification:&#xD;
AEs (Exclude expected menstruation and treatment ineffective)&#xD;
Dissatisfaction with bleeding profile&#xD;
Absence of symptoms&#xD;
Treatment ineffective&#xD;
Physicians decision&#xD;
Switching to another treatment (another medicine or surgery)&#xD;
Wish to conceive&#xD;
Others</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne</measure>
    <time_frame>At baseline, 1, 3, and 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">969</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Visanne treatment</arm_group_label>
    <description>Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dienogest (Visanne,BAY86_5258)</intervention_name>
    <description>2 mg (once a day), oral, tablet.</description>
    <arm_group_label>Visanne treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese patients from post-menarche to menopause diagnosed with endometriosis, either&#xD;
        surgically or clinically, and prescribed with Visanne by a physician according to China's&#xD;
        health authority approved label.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Post-menarcheal age through menopause.&#xD;
&#xD;
          -  Have clinically or surgically diagnosed endometriosis according to routine clinical&#xD;
             practice.&#xD;
&#xD;
          -  Decision for the treatment with Visanne was made as per physician's routine treatment&#xD;
             practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in an investigational program with interventions outside of&#xD;
             routine clinical practice.&#xD;
&#xD;
          -  Any contraindication according to Visanne Chinese label&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dienogest</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.</ipd_description>
  </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/NCT04495855
org study id: 21088
nct id: NCT04495855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endometriosis is a condition that affects women, usually during their reproductive years. In
      women with endometriosis, the tissue that lines the uterus starts to grow outside of the
      uterus. This can cause pain during their periods or during sex, and constant pain in the
      pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment
      to control the symptoms.

      For some women with endometriosis, symptoms can return after they stop treatment. Or, they
      may not be able to tolerate the current long-term treatment options.

      In this study, researchers will find out more about the safety of long-term treatment with
      dienogest in a large number of Chinese participants. This study will enroll patients from
      post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the
      participants will take dienogest based on their doctor's instructions. They will then visit
      their doctor's office 3 times over 6 months. During these visits, their doctors will ask them
      if they have any health problems and about their quality of life. Their doctors will also do
      tests to measure the pain caused by their endometriosis and any other symptoms.
observational model: Cohort
time perspective: Prospective
measure: The absolute number of AEs reported with Visanne treatment
time frame: From baseline up to 6 months
description: AE: Adverse Event
measure: The absolute number of ADRs reported with Visanne treatment
time frame: From baseline up to 6 months
description: ADR: Adverse drug reaction
measure: The proportion of AEs reported with Visanne treatment
time frame: From baseline up to 6 months
description: Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.
measure: The proportion of ADRs reported with Visanne treatment
time frame: From baseline up to 6 months
description: Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.
measure: Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment
time frame: From baseline up to 1,3,6 months
description: NRS: 0-10 integers."absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "10".
measure: Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment
time frame: At baseline and 6 months.
description: EHP-5 contains 11 questions (items): five items including pain, control and powerlessness, emotional well-being, lack of social support, self image from the core questionnaire and six items from the modular questionnaire that may not be applicable to every woman with endometriosis including work, intercourse, and worries about infertility, treatment, and relationship with children and medical professionals. Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable).
measure: Patient and physician's satisfaction score on Visanne® treatment
time frame: At 3 and 6 months
description: Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)
measure: Changes in Clinical Global Impression (CGI) scale scores of overall symptom development
time frame: At 3 and 6 months
description: CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
measure: Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development
time frame: At 3 and 6 months
description: PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
measure: Reasons for discontinuation of using Visanne
time frame: From baseline up to 6 months
description: Discontinuation reasons identification:
AEs (Exclude expected menstruation and treatment ineffective)
Dissatisfaction with bleeding profile
Absence of symptoms
Treatment ineffective
Physicians decision
Switching to another treatment (another medicine or surgery)
Wish to conceive
Others
measure: The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne
time frame: At baseline, 1, 3, and 6 months
arm group label: Visanne treatment
description: Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne
intervention type: Drug
intervention name: Dienogest (Visanne,BAY86_5258)
description: 2 mg (once a day), oral, tablet.
arm group label: Visanne treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Dienogest
sharing ipd: No
ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.