<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/NCT03240523</url>
  </required_header>
  <id_info>
    <org_study_id>15789</org_study_id>
    <secondary_id>2016-002855-48</secondary_id>
    <nct_id>NCT03240523</nct_id>
  </id_info>
  <brief_title>Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids</brief_title>
  <acronym>ASTEROID 5</acronym>
  <official_title>A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids</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>
      The primary objective of this study is to describe the efficacy of vilaprisan in subjects&#xD;
      with uterine fibroids compared to ulipristal.&#xD;
&#xD;
      The secondary objective of this study is to evaluate the efficacy and safety of different&#xD;
      treatment regimens of vilaprisan in subjects with uterine fibroids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to a change in the development program, the study was closed prematurely.&#xD;
  </why_stopped>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">October 25, 2021</completion_date>
  <primary_completion_date type="Actual">June 28, 2020</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>None (Open Label)</masking>
    <masking_description>With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Amenorrhea (yes/no)</measure>
    <time_frame>At 3 months (at the end of treatment perid 1)</time_frame>
    <description>Defined as menstrual blood loss (MBL) &lt; 2 mL based on the menstrual pictogram (MP) during last 28 days.&#xD;
For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total volume of menstrual blood loss</measure>
    <time_frame>After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2</time_frame>
    <description>Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of bleeding days</measure>
    <time_frame>After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2</time_frame>
    <description>From day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amenorrhea (yes/no)</measure>
    <time_frame>At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months</time_frame>
    <description>Defined as menstrual blood loss (MBL) &lt; 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence of bleeding (spotting allowed)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of controlled bleeding</measure>
    <time_frame>Quarterly up to 24 months</time_frame>
    <description>Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HMB (Heavy Menstrual Bleeding) responder rate</measure>
    <time_frame>By treatment period up to 24 months</time_frame>
    <description>Percentage of subjects with blood loss &lt; 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in volume of largest fibroid compared to baseline</measure>
    <time_frame>At baseline, at 12 months and at 24 months</time_frame>
    <description>Measured by MRI (magnetic resonance imaging).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometrial histology</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>E.g., benign endometrium, presence or absence of hyperplasia or malignancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometrial thickness</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">766</enrollment>
  <condition>Uterine Fibroids</condition>
  <arm_group>
    <arm_group_label>Group A1: Vilaprisan (3/1 regimen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A2: Vilaprisan (6/2 regimen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A3/B (3/2 regimen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes&#xD;
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vilaprisan (BAY1002670)</intervention_name>
    <description>Orally, 2 mg, once daily</description>
    <arm_group_label>Group A1: Vilaprisan (3/1 regimen)</arm_group_label>
    <arm_group_label>Group A2: Vilaprisan (6/2 regimen)</arm_group_label>
    <arm_group_label>Group A3/B (3/2 regimen)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, 18 years or older at the time of Visit 1&#xD;
&#xD;
          -  Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1&#xD;
             fibroid with largest diameter more than 30 mm and less than 120 mm&#xD;
&#xD;
          -  Heavy menstrual bleeding (HMB) &gt;80.00 mL documented by menstrual pictogram (MP) in a&#xD;
             bleeding episode period during the screening period&#xD;
&#xD;
          -  Use of an acceptable non-hormonal method of contraception&#xD;
&#xD;
          -  An endometrial biopsy performed during the screening period, without significant&#xD;
             histological disorder such as endometrial hyperplasia (including simple hyperplasia)&#xD;
             or other significant endometrial pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation&#xD;
             before start of treatment)&#xD;
&#xD;
          -  Hypersensitivity to any ingredient of the study drugs&#xD;
&#xD;
          -  Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion&#xD;
             (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron&#xD;
             supplementation)&#xD;
&#xD;
          -  Any diseases, conditions, or medications that can compromise the function of the body&#xD;
             systems and could result in altered absorption, excessive accumulation, impaired&#xD;
             metabolism, or altered excretion of the study drug including&#xD;
&#xD;
          -  Abuse of alcohol, drugs, or medicines (eg: laxatives)&#xD;
&#xD;
          -  Undiagnosed abnormal genital bleeding&#xD;
&#xD;
          -  Any diseases or conditions that might interfere with the conduct of the study or the&#xD;
             interpretation of the results&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 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>
      <name>Paratus Clinical Pty Ltd</name>
      <address>
        <city>Blacktown</city>
        <state>New South Wales</state>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Wyong Complex</name>
      <address>
        <city>Kanwal</city>
        <state>New South Wales</state>
        <zip>2259</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health and Research Institute of Australia-WHRIA</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenslopes Private Hospital</name>
      <address>
        <city>Greenslopes</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Graz</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Bregenz</name>
      <address>
        <city>Bregenz</city>
        <state>Vorarlberg</state>
        <zip>6900</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum AKH Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Jan Palfijn Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Pierre/UMC Sint-Pieter</name>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CU Saint-Luc/UZ St-Luc</name>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Tivoli</name>
      <address>
        <city>La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR de la Citadelle - Department of Gynaecology &amp; Obstetrics</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Femicare vzw</name>
      <address>
        <city>Tienen</city>
        <zip>3300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Blagoevgrad AD</name>
      <address>
        <city>Blagoevgrad</city>
        <zip>2700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dobrich</name>
      <address>
        <city>Dobrich</city>
        <zip>9300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC Asklepii OOD</name>
      <address>
        <city>Dupnitsa</city>
        <zip>2600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Uni Hospital OOD</name>
      <address>
        <city>Panagyurishte</city>
        <zip>4500</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Avis Medika</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spec. Hospital for Active Treatment of Oncological Diseases</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCC Aleksandrovska</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Panaceya</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Niamed</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Sv. Anna</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHOGAT Prof Dimitar Stamatov</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean West Research Clinic Inc</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3S 2N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strand Clinic</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1A 4Y3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital-Riverside Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique OVO</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4P 2S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Recherche en Sante des Femmes Inc.</name>
      <address>
        <city>Quebec</city>
        <zip>G1S 2L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de recherche Saint-Louis</name>
      <address>
        <city>Quebec</city>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ALPHA Recherche Clinique</name>
      <address>
        <city>Quebec</city>
        <zip>G3K 2P8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gynekologicka ordinace - Ceske Budejovice</name>
      <address>
        <city>Ceske Budejovice</city>
        <zip>370 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G-Centrum Olomouc s.r.o. Dr. Skrivanek</name>
      <address>
        <city>Olomouc</city>
        <zip>772 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum gynekologicke rehabilitace</name>
      <address>
        <city>Pisek</city>
        <zip>39701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUDr. Martina Maresova Rosenbergova, gynekologie</name>
      <address>
        <city>Plzen</city>
        <zip>300 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Smrhova-Kovacs</name>
      <address>
        <city>Tabor</city>
        <zip>39003</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediGyn s.r.o.</name>
      <address>
        <city>Trebon</city>
        <zip>379 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GYNEKO spol. s r.o.</name>
      <address>
        <city>Vsetin</city>
        <zip>755 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital, Skejby</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjælland Hospital Hillerød</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HUS / Naistenklinikka</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VL-Medi Oy</name>
      <address>
        <city>Helsinki</city>
        <zip>00510</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymenlaakson keskussairaala</name>
      <address>
        <city>Kotka</city>
        <zip>48210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lääkäriasema Cantti Oy</name>
      <address>
        <city>Kuopio</city>
        <zip>70110</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lääkärikeskus Gyneko</name>
      <address>
        <city>Oulu</city>
        <zip>90100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turun yliopistollinen keskussairaala</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxisklinik am Rosengarten</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68165</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frauenarztpraxis Dr. Wolfgang Clemens</name>
      <address>
        <city>Stolberg</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52222</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis f. Gynäkologie und Geburtshilfe</name>
      <address>
        <city>Bernburg</city>
        <state>Sachsen-Anhalt</state>
        <zip>06406</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>emovis GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10629</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Principal SMO Kft.</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba</name>
      <address>
        <city>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tritonlife Robert Magankorhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1135</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Anna szuleszeti-nogyogyaszati maganrendelo</name>
      <address>
        <city>Debrecen</city>
        <zip>4024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NAP - Rendelo, Private Clinic</name>
      <address>
        <city>Debrecen</city>
        <zip>4028</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Komaromi Selye Janos Korhaz</name>
      <address>
        <city>Komarom</city>
        <zip>2900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SzSzBMK es EOK Josa Andras Oktatokorhaz</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midland Regional Hospital</name>
      <address>
        <city>Mullingar</city>
        <state>Westmeath</state>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico G.Rodolico-San Marco</name>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Ospedali Riuniti Villa Sofia-Cervello</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Careggi</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U.I. Verona</name>
      <address>
        <city>Verona</city>
        <state>Veneto</state>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk University Ilsan Hospital</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggido</state>
        <zip>10326</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggido</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <zip>443-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>612-862</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangnam Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Gangnam Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-081</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>152-703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>158-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jsc &quot;Vakk&quot;</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-51028</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klaipeda City Outpatient Clinic</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-93200</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JSC Seimos gydytojas family medical center</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-01118</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JSC Gyvenk Silciau Medical Center Maxmeda</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-03225</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private hospital and outpatient clinic &quot;Kardiolita&quot;</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-05263</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital Santaros Klinikos</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flevoziekenhuis</name>
      <address>
        <city>Almere</city>
        <zip>1315 RA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VUmc</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maasstad Ziekenhuis | Neurology Department</name>
      <address>
        <city>Rotterdam</city>
        <zip>3079DZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kirkeparken Spesialistpraksis</name>
      <address>
        <city>Fredrikstad</city>
        <zip>1605</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nesttun Spesialistpraksis AS</name>
      <address>
        <city>Nesttun</city>
        <zip>5221</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicus Oslo AS</name>
      <address>
        <city>Oslo</city>
        <zip>0161</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger Universitetssjukehus</name>
      <address>
        <city>Stavanger</city>
        <zip>4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicus AS</name>
      <address>
        <city>Trondheim</city>
        <zip>7014</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomaszewski Medical Center</name>
      <address>
        <city>Bialystok</city>
        <zip>15-084</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatna Klinika Ginekologiczno-Poloznicza</name>
      <address>
        <city>Bialystok</city>
        <zip>15-244</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINICAL MEDICAL RESEARCH Sp. z o. o.</name>
      <address>
        <city>Katowice</city>
        <zip>40-156</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vita Longa Sp. z o.o.</name>
      <address>
        <city>Katowice</city>
        <zip>40-748</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medico Praktyka Lekarska</name>
      <address>
        <city>Krakow</city>
        <zip>31-315</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.</name>
      <address>
        <city>Lodz</city>
        <zip>90-602</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Chodzki</name>
      <address>
        <city>Lublin</city>
        <zip>20-093</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczny Gabinet Ginekologiczno-Polozniczy</name>
      <address>
        <city>Lublin</city>
        <zip>20-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C</name>
      <address>
        <city>Lublin</city>
        <zip>20-632</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VitroLive Sp. z o.o.</name>
      <address>
        <city>Szczecin</city>
        <zip>70-483</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Zieniewicz Medical</name>
      <address>
        <city>Warszawa</city>
        <zip>02-201</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badawcze Wspolczesnej Terapii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-679</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Clinico Academico - Braga</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUC - Hospitais da Universidade de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Lisboa Ocidental | Clin Res Dept</name>
      <address>
        <city>Lisboa</city>
        <zip>1449-005</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerzitna nemocnica Bratislava, Nemocnica Ruzinov</name>
      <address>
        <city>Bratislava 2</city>
        <zip>826 06</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ULMUS, s r.o.</name>
      <address>
        <city>Hlohovec</city>
        <zip>920 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GA Lucenec s.r.o</name>
      <address>
        <city>Lucenec</city>
        <zip>984 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galipea s.r.o.</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyncentrum Nitra s.r.o.</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virina sano, s.r.o. Gynekologicko porodnicka ambulancia</name>
      <address>
        <city>Velky Krtis</city>
        <zip>990 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sanitas La Zarzuela</name>
      <address>
        <city>Aravaca</city>
        <state>Madrid</state>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ginemed</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Virgen del Rocio |Cardiology|AF|Stroke prevention</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Álava - Sede Txagorritxu</name>
      <address>
        <city>Vitoria</city>
        <state>Álava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Södersjukhuset AB</name>
      <address>
        <city>Stockholm</city>
        <zip>118 83</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset i Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danderyds sjukhus</name>
      <address>
        <city>Stockholm</city>
        <zip>182 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mackay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital at Linkou</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Hampshire Hospital</name>
      <address>
        <city>Basingstoke</city>
        <state>Hampshire</state>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Middlesex University Hospital</name>
      <address>
        <city>London</city>
        <zip>N18 1QX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whittington Hospital</name>
      <address>
        <city>London</city>
        <zip>N19 5NF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea &amp; Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's Hospital (London)</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Lithuania</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Latvia</country>
    <country>Ukraine</country>
  </removed_countries>
  <link>
    <url>http://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer Healthcare products conducted in Europe</description>
  </link>
  <link>
    <url>http://clinicaltrials.bayer.com</url>
    <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 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>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_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/NCT03240523
org study id: 15789
secondary id: 2016-002855-48
nct id: NCT03240523
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to describe the efficacy of vilaprisan in subjects
      with uterine fibroids compared to ulipristal.

      The secondary objective of this study is to evaluate the efficacy and safety of different
      treatment regimens of vilaprisan in subjects with uterine fibroids.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
measure: Amenorrhea (yes/no)
time frame: At 3 months (at the end of treatment perid 1)
description: Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days.
For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.
measure: Total volume of menstrual blood loss
time frame: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
description: Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.
measure: Number of bleeding days
time frame: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
description: From day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days.
measure: Amenorrhea (yes/no)
time frame: At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
description: Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.
measure: Absence of bleeding (spotting allowed)
time frame: Up to 24 months
description: Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary).
measure: Time to onset of controlled bleeding
time frame: Quarterly up to 24 months
description: Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL.
measure: HMB (Heavy Menstrual Bleeding) responder rate
time frame: By treatment period up to 24 months
description: Percentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]
measure: Percent change in volume of largest fibroid compared to baseline
time frame: At baseline, at 12 months and at 24 months
description: Measured by MRI (magnetic resonance imaging).
measure: Endometrial histology
time frame: Up to 24 months
description: E.g., benign endometrium, presence or absence of hyperplasia or malignancy
measure: Endometrial thickness
time frame: Up to 24 months
arm group label: Group A1: Vilaprisan (3/1 regimen)
arm group type: Experimental
description: Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
arm group label: Group A2: Vilaprisan (6/2 regimen)
arm group type: Experimental
description: Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
arm group label: Group A3/B (3/2 regimen)
arm group type: Experimental
description: Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
intervention type: Drug
intervention name: Vilaprisan (BAY1002670)
description: Orally, 2 mg, once daily
arm group label: Group A1: Vilaprisan (3/1 regimen)
arm group label: Group A2: Vilaprisan (6/2 regimen)
arm group label: Group A3/B (3/2 regimen)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Czechia
country: Denmark
country: Finland
country: Germany
country: Hungary
country: Ireland
country: Italy
country: Korea, Republic of
country: Lithuania
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Slovakia
country: Spain
country: Sweden
country: Taiwan
country: United Kingdom
country: France
country: Latvia
country: Ukraine
url: http://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer Healthcare products conducted in Europe
url: http://clinicaltrials.bayer.com
description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma
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.