<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/NCT03027973</url>
  </required_header>
  <id_info>
    <org_study_id>PBLL07230904</org_study_id>
    <secondary_id>16-155</secondary_id>
    <nct_id>NCT03027973</nct_id>
  </id_info>
  <brief_title>Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding</brief_title>
  <official_title>Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</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>
      This study compares two treatments for the management of heavy menstrual bleeding, ulipristal&#xD;
      acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half of the&#xD;
      participants will receive UPA and a placebo, and the other half will receive TEA and a&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      UPA is approved by Health Canada for the treatment of signs and symptoms of uterine fibroids&#xD;
      in adult women of reproductive age who are eligible for surgery. UPA is considered&#xD;
      investigational for this study, as it has not been approved by Health Canada for the&#xD;
      treatment of heavy menstrual bleeding in women who do not have uterine fibroids.&#xD;
&#xD;
      TEA is approved by Health Canada for prevention or reduction of bleeding in different&#xD;
      conditions, including heavy periods. This treatment is available as part of routine care for&#xD;
      regular heavy menstrual bleeding and is being used as the comparison treatment in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI made the decision to not continue the study. It was at the Health Canada review stage.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2020</start_date>
  <completion_date type="Actual">January 17, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months</measure>
    <time_frame>At Baseline and repeated 3 months later</time_frame>
    <description>The MMAS measures the impact of menorrhagia on health related quality of life (QoL) in six domains.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events that occur</measure>
    <time_frame>From Baseline visit to end of study 3 months later</time_frame>
    <description>The subjective change in symptoms will be assessed based on recordings in the study diaries.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heavy Menstrual Bleeding</condition>
  <arm_group>
    <arm_group_label>UPA Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UPA 5mg capsule daily + Placebo 2 capsules 4 times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TEA Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UPA</intervention_name>
    <description>Experimental drug</description>
    <arm_group_label>UPA Treatment Group</arm_group_label>
    <other_name>Ulipristal Acetate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TEA</intervention_name>
    <description>Active comparator</description>
    <arm_group_label>TEA Treatment Group</arm_group_label>
    <other_name>Tranexamic Acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for UPA)</intervention_name>
    <description>Sugar pill manufactured to mimic UPA 5 mg</description>
    <arm_group_label>TEA Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for TEA)</intervention_name>
    <description>Sugar pill manufactured to mimic TEA 500mg</description>
    <arm_group_label>UPA Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are female and have a uterus&#xD;
&#xD;
          -  Participants are between the ages of 18 and 51 years at the time of consent&#xD;
&#xD;
          -  Participants have heavy menstrual bleeding as evidenced by their symptoms of&#xD;
             subjective increased bleeding volume and desire to seek treatment&#xD;
&#xD;
          -  The symptom of heavy menstrual bleeding has been present for most of the last 6 months&#xD;
&#xD;
          -  Participants have regular menstrual cycles between 24 -38 days in length&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are pregnant or have a positive urine β-hCG&#xD;
&#xD;
          -  Participants whose bleeding is coming from a cervical, vaginal, urinary or&#xD;
             gastrointestinal source&#xD;
&#xD;
          -  Participants who are found to have or who have a previous diagnosis of uterine or&#xD;
             cervical polyps, adenomyosis, or leiomyomas (fibroids)&#xD;
&#xD;
          -  Participants who are found to have or who have had endometrial hyperplasia, cervical&#xD;
             dysplasia or malignancy of any of the vulva, cervix, endometrium, breast or ovaries.&#xD;
&#xD;
          -  Participants who have ovulatory dysfunction as defined by menstrual cycles that are&#xD;
             irregular in frequency and regularity and are often punctuated with periods of&#xD;
             amenorrhea&#xD;
&#xD;
          -  Participants who are found to have or who have been diagnosed with a coagulopathy&#xD;
&#xD;
          -  Participants who have a current genitourinary infection&#xD;
&#xD;
          -  Participants who are desirous of becoming pregnant within the next four months&#xD;
&#xD;
          -  Participants who have untreated or inadequately treated thyroid disease&#xD;
&#xD;
          -  Participants who have a contraindication to either treatment including&#xD;
             hypersensitivity&#xD;
&#xD;
          -  Participants who are breastfeeding&#xD;
&#xD;
          -  Participants with mild, moderate or severe hepatic impairment&#xD;
&#xD;
          -  Participants with moderate or severe renal impairment&#xD;
&#xD;
          -  Participants with severe asthma not controlled with oral glucocorticoids&#xD;
&#xD;
          -  Participants with active disease, or history of deep vein thrombosis (DVT), pulmonary&#xD;
             embolism (PE), cerebral thrombosis or with family history of thromboembolic disease&#xD;
&#xD;
          -  Patients with subarachnoid hemorrhage&#xD;
&#xD;
          -  Patients with acquired disturbances of colour vision&#xD;
&#xD;
          -  Participants who are already on hormone based treatment including, progesterone only&#xD;
             pills, combined oral contraceptive pill (COCP), Intrauterine System (IUS)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Almereau Prollius, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saskatoon Obstetric and Gynecologic Consultants</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7K 1N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 25, 2020</last_update_submitted>
  <last_update_submitted_qc>January 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Almereau Prollius</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
    <mesh_term>Ulipristal acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03027973
org study id: PBLL07230904
secondary id: 16-155
nct id: NCT03027973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares two treatments for the management of heavy menstrual bleeding, ulipristal
      acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half of the
      participants will receive UPA and a placebo, and the other half will receive TEA and a
      placebo.
UPA is approved by Health Canada for the treatment of signs and symptoms of uterine fibroids
      in adult women of reproductive age who are eligible for surgery. UPA is considered
      investigational for this study, as it has not been approved by Health Canada for the
      treatment of heavy menstrual bleeding in women who do not have uterine fibroids.

      TEA is approved by Health Canada for prevention or reduction of bleeding in different
      conditions, including heavy periods. This treatment is available as part of routine care for
      regular heavy menstrual bleeding and is being used as the comparison treatment in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
time frame: At Baseline and repeated 3 months later
description: The MMAS measures the impact of menorrhagia on health related quality of life (QoL) in six domains.
measure: Number of adverse events that occur
time frame: From Baseline visit to end of study 3 months later
description: The subjective change in symptoms will be assessed based on recordings in the study diaries.
arm group label: UPA Treatment Group
arm group type: Experimental
description: UPA 5mg capsule daily + Placebo 2 capsules 4 times a day
arm group label: TEA Treatment Group
arm group type: Active Comparator
description: TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily
intervention type: Drug
intervention name: UPA
description: Experimental drug
arm group label: UPA Treatment Group
other name: Ulipristal Acetate
intervention type: Drug
intervention name: TEA
description: Active comparator
arm group label: TEA Treatment Group
other name: Tranexamic Acid
intervention type: Drug
intervention name: Placebo (for UPA)
description: Sugar pill manufactured to mimic UPA 5 mg
arm group label: TEA Treatment Group
intervention type: Drug
intervention name: Placebo (for TEA)
description: Sugar pill manufactured to mimic TEA 500mg
arm group label: UPA Treatment Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 51 Years
healthy volunteers: No
last name: Almereau Prollius, MD
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Almereau Prollius
investigator title: M.D.
mesh term: Menorrhagia
mesh term: Hemorrhage
mesh term: Tranexamic Acid
mesh term: Ulipristal acetate
sharing ipd: No