<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/NCT02262663</url>
  </required_header>
  <id_info>
    <org_study_id>15818</org_study_id>
    <secondary_id>2014-000329-19</secondary_id>
    <nct_id>NCT02262663</nct_id>
  </id_info>
  <brief_title>Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan</brief_title>
  <official_title>A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age</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 study in healthy women of reproductive age to investigate the pharmacodynamics&#xD;
      (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral&#xD;
      administration of 4 different doses over 84 days, using a randomized, parallel-group,&#xD;
      multicenter design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hoogland score during treatment, day 9 to day 28</measure>
    <time_frame>Day 9 to 28</time_frame>
    <description>based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hoogland score during treatment, day 63 to day 84</measure>
    <time_frame>Day 63 to 84</time_frame>
    <description>based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hoogland score during follow up cycle 1</measure>
    <time_frame>4 weeks following treatment period</time_frame>
    <description>based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hoogland score during follow up cycle 2</measure>
    <time_frame>4 weeks following follow up cycle 1</time_frame>
    <description>based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects without bleeding/spotting</measure>
    <time_frame>After three month treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling</measure>
    <time_frame>After three month treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with TEAEs (treatment-emergent adverse events)</measure>
    <time_frame>After three month treatment and during follow-up (up to 60 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)</measure>
    <time_frame>After three month treatment and during follow-up (up to 60 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Clinical Trial, Phase I</condition>
  <arm_group>
    <arm_group_label>Vilaprisan [0.5mg]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vilaprisan [1mg]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vilaprisan [2mg]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vilaprisan [4mg]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vilaprisan (BAY1002670)</intervention_name>
    <arm_group_label>Vilaprisan [0.5mg]</arm_group_label>
    <arm_group_label>Vilaprisan [1mg]</arm_group_label>
    <arm_group_label>Vilaprisan [2mg]</arm_group_label>
    <arm_group_label>Vilaprisan [4mg]</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit&#xD;
&#xD;
          -  Absence of clinically relevant abnormal findings in the pre-treatment endometrial&#xD;
             biopsy&#xD;
&#xD;
          -  Pre-treatment cycle assessed as ovulatory and not longer than 44 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incompletely cured pre-existing diseases for which it can be assumed that the&#xD;
             absorption, distribution, metabolism, elimination or effects of the study drugs will&#xD;
             not be normal&#xD;
&#xD;
          -  Known or suspected liver disorders&#xD;
&#xD;
          -  Amenorrhea for more than 3 months within the last 6 months before the first screening&#xD;
             examination&#xD;
&#xD;
          -  Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical&#xD;
             and gynecological examination, laboratory examination)&#xD;
&#xD;
          -  Positive urine pregnancy test&#xD;
&#xD;
          -  Regular use of medicines&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>Berlin</city>
        <zip>10115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>March 14, 2016</last_update_submitted>
  <last_update_submitted_qc>March 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02262663
org study id: 15818
secondary id: 2014-000329-19
nct id: NCT02262663
lead sponsor: 
has dmc: No
This is a study in healthy women of reproductive age to investigate the pharmacodynamics
      (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral
      administration of 4 different doses over 84 days, using a randomized, parallel-group,
      multicenter design.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hoogland score during treatment, day 9 to day 28
time frame: Day 9 to 28
description: based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
measure: Hoogland score during treatment, day 63 to day 84
time frame: Day 63 to 84
description: based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
measure: Hoogland score during follow up cycle 1
time frame: 4 weeks following treatment period
description: based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
measure: Hoogland score during follow up cycle 2
time frame: 4 weeks following follow up cycle 1
description: based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
measure: Number of subjects without bleeding/spotting
time frame: After three month treatment
measure: Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling
time frame: After three month treatment
measure: Number of subjects with TEAEs (treatment-emergent adverse events)
time frame: After three month treatment and during follow-up (up to 60 days)
measure: Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)
time frame: After three month treatment and during follow-up (up to 60 days)
arm group label: Vilaprisan [0.5mg]
arm group type: Experimental
description: 0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
arm group label: Vilaprisan [1mg]
arm group type: Experimental
description: 1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
arm group label: Vilaprisan [2mg]
arm group type: Experimental
description: 2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
arm group label: Vilaprisan [4mg]
arm group type: Experimental
description: 4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
intervention type: Drug
intervention name: Vilaprisan (BAY1002670)
arm group label: Vilaprisan [0.5mg]
arm group label: Vilaprisan [1mg]
arm group label: Vilaprisan [2mg]
arm group label: Vilaprisan [4mg]
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
country: Germany
responsible party type: Sponsor