<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/NCT01697111</url>
  </required_header>
  <id_info>
    <org_study_id>15457</org_study_id>
    <nct_id>NCT01697111</nct_id>
  </id_info>
  <brief_title>Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis</brief_title>
  <official_title>A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study&#xD;
      (24-week treatment-comparison phase) with an open-label reference arm of active comparator&#xD;
      (dienogest) followed by 28-week long-term treatment phase.&#xD;
&#xD;
      The primary objective of this study is to confirm the superiority of BAY86-5300 when&#xD;
      administered with an extended flexible regimen for the treatment of endometriosis-associated&#xD;
      pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.&#xD;
&#xD;
      The secondary objective is to investigate the long-term safety of BAY86-5300 in patients&#xD;
      treated with an extended flexible regimen for one year, and the bleeding pattern of&#xD;
      BAY86-5300 when administered with an extended flexible regimen compared to dienogest.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)</measure>
    <time_frame>Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)</time_frame>
    <description>The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)</measure>
    <time_frame>Weeks 17-24 of treatment period</time_frame>
    <description>Pelvic pain is the worst pain on a 0-10 scale rated by the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)</measure>
    <time_frame>Weeks 17-24 of treatment period</time_frame>
    <description>Pelvic pain is the worst pain on a 0-10 scale rated by the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspareunia</measure>
    <time_frame>Weeks 17-24 of treatment period</time_frame>
    <description>In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average of pain</measure>
    <time_frame>Weeks 17-24 of treatment period</time_frame>
    <description>The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of chocolate cyst</measure>
    <time_frame>24 weeks after taking the initial study medication</time_frame>
    <description>In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometrial thickness</measure>
    <time_frame>24 weeks after taking the initial study medication</time_frame>
    <description>Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with spotting/bleeding</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>Number of days with spotting/bleeding is determined based on daily record of Patient Diary.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">312</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EE20/DRSP(BAY86-5300)</intervention_name>
    <description>One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dienogest</intervention_name>
    <description>Dienogest 1mg twice a day (bid)</description>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by&#xD;
             identification of chocolate cyst of endometriosis, or patients with the clinical&#xD;
             diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or&#xD;
             induration of Cul-de-sac or uterine immobility&#xD;
&#xD;
          -  Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40&#xD;
             mm or higher which is determined during 2 menstrual cycles before randomization&#xD;
             (baseline observation phase)&#xD;
&#xD;
          -  Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses&#xD;
             before randomization (baseline observation phase)&#xD;
&#xD;
          -  Patients who do not wish to become pregnant during the course of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have organic diseases of which surgical treatment is prioritized by&#xD;
             investigator&#xD;
&#xD;
          -  Patients in whom any hormonal therapies, including combined oral contraceptives (COCs)&#xD;
             and progestins, have failed for treatment of symptomatic endometriosis (moderate,&#xD;
             severe pain)&#xD;
&#xD;
          -  Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese&#xD;
             Labeling)&#xD;
&#xD;
          -  Patients for whom dienogest is contraindicated (according to Japanese labeling of&#xD;
             Dinagest Tab 1mg)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Anjo</city>
        <state>Aichi</state>
        <zip>446-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ichinomiya</city>
        <state>Aichi</state>
        <zip>491-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>451-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>460-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-0066</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Matsudo</city>
        <state>Chiba</state>
        <zip>270-2267</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Takasaki</city>
        <state>Gunma</state>
        <zip>370-0883</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Itami</city>
        <state>Hyogo</state>
        <zip>664-8540</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kawanishi</city>
        <state>Hyogo</state>
        <zip>666-0125</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>654-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kamakura</city>
        <state>Kanagawa</state>
        <zip>247-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>212-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>230-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>231-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toyonaka</city>
        <state>Osaka</state>
        <zip>560-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kitamoto</city>
        <state>Saitama</state>
        <zip>364-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bunkyo</city>
        <state>Tokyo</state>
        <zip>112-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fuchu</city>
        <state>Tokyo</state>
        <zip>183-0056</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <zip>192-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Itabashi</city>
        <state>Tokyo</state>
        <zip>175-0092</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Machida</city>
        <state>Tokyo</state>
        <zip>194-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minato</city>
        <state>Tokyo</state>
        <zip>105-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minato</city>
        <state>Tokyo</state>
        <zip>107-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nishitokyo</city>
        <state>Tokyo</state>
        <zip>188-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukui</city>
        <zip>910-0845</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukui</city>
        <zip>910-8526</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gifu</city>
        <zip>500-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <zip>530-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <zip>530-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <zip>542-0086</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 28, 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>February 16, 2016</last_update_submitted>
  <last_update_submitted_qc>February 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>YAZ</keyword>
  <keyword>Flexible regimen</keyword>
  <keyword>Drospirenone</keyword>
  <keyword>Ethinylestradiol Betadex</keyword>
  <keyword>Endometriosis</keyword>
  <keyword>Dienogest</keyword>
  <keyword>Japanese Patients</keyword>
  <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>
  <!-- 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/NCT01697111
org study id: 15457
nct id: NCT01697111
lead sponsor: 
has dmc: No
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study
      (24-week treatment-comparison phase) with an open-label reference arm of active comparator
      (dienogest) followed by 28-week long-term treatment phase.

      The primary objective of this study is to confirm the superiority of BAY86-5300 when
      administered with an extended flexible regimen for the treatment of endometriosis-associated
      pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.

      The secondary objective is to investigate the long-term safety of BAY86-5300 in patients
      treated with an extended flexible regimen for one year, and the bleeding pattern of
      BAY86-5300 when administered with an extended flexible regimen compared to dienogest.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)
time frame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)
description: The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)
measure: Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)
time frame: Weeks 17-24 of treatment period
description: Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
measure: Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)
time frame: Weeks 17-24 of treatment period
description: Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
measure: Dyspareunia
time frame: Weeks 17-24 of treatment period
description: In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.
measure: Average of pain
time frame: Weeks 17-24 of treatment period
description: The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.
measure: Size of chocolate cyst
time frame: 24 weeks after taking the initial study medication
description: In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.
measure: Endometrial thickness
time frame: 24 weeks after taking the initial study medication
description: Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
measure: Number of days with spotting/bleeding
time frame: Up to 52 weeks
description: Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
arm group label: Arm 1
arm group type: Experimental
arm group label: Arm 2
arm group type: Experimental
arm group label: Arm 3
arm group type: Active Comparator
intervention type: Drug
intervention name: EE20/DRSP(BAY86-5300)
description: One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
arm group label: Arm 1
intervention type: Drug
intervention name: Placebo
description: One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively
arm group label: Arm 2
intervention type: Drug
intervention name: Dienogest
description: Dienogest 1mg twice a day (bid)
arm group label: Arm 3
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Japan
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Dienogest