<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/NCT04478305</url>
  </required_header>
  <id_info>
    <org_study_id>2019-7333</org_study_id>
    <nct_id>NCT04478305</nct_id>
  </id_info>
  <brief_title>Affect of Duavive on Mood &amp; Anxiety Symptoms</brief_title>
  <acronym>DOMA</acronym>
  <official_title>The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood&#xD;
      (depression and anxiety) in peri- and early menopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the transition to menopause, women are at risk for developing symptoms of depression&#xD;
      and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in&#xD;
      this. The investigators suspect that the administration of estrogens without progesterone,&#xD;
      such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this&#xD;
      population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada,&#xD;
      but the effect on mood were not examined closely.&#xD;
&#xD;
      The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently&#xD;
      seeking treatment for symptoms of depression or anxiety. The participants will go through a&#xD;
      round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to&#xD;
      determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and&#xD;
      secondarily if treatment with CE/BZA improves their sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2021</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group longitudinal study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 4 weeks weeks after beginning study</time_frame>
    <description>Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 4 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>At 4 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Menopause symptoms</measure>
    <time_frame>At 4 weeks after beginning study</time_frame>
    <description>Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopause symptoms</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopause symptoms</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopause symptoms</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total nightly sleep time</measure>
    <time_frame>At 4 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total nightly sleep time</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total nightly sleep time</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total nightly sleep time</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep onset latency</measure>
    <time_frame>At 4 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep onset latency</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep onset latency</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep onset latency</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset</measure>
    <time_frame>At 4 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset</measure>
    <time_frame>At 8 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset</measure>
    <time_frame>At 12 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset</measure>
    <time_frame>At 16 weeks after beginning study</time_frame>
    <description>Assessed by an Actigraph 2 monitor</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Menopause</condition>
  <condition>Depression, Anxiety</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient will be provided with study medication. To be taken once a day for 16 weeks (112 days). Active drug brand name - Duavive/Duavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duavive 0.45Mg-20Mg Tablet</intervention_name>
    <description>Duavee, marketed as Duavive in Canada.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Duavive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females between 45-60 years of age&#xD;
&#xD;
          -  Able to communicate in English&#xD;
&#xD;
          -  In perimenopause as defined by World Health Organization (WHO) STages of Reproductive&#xD;
             Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final&#xD;
             menstrual period)&#xD;
&#xD;
          -  Suffering from Depressive symptoms (16+ on CES-D) AND/OR anxiety symptoms (10+ on&#xD;
             GAD-7)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.&#xD;
&#xD;
          -  Abnormal uterine bleeding that has not been adequately investigated.&#xD;
&#xD;
          -  Active or past venous or arterial thromboembolic disease (deep vein thrombosis,&#xD;
             pulmonary embolism, stroke, myocardial infarction, coronary heart disease).&#xD;
&#xD;
          -  Active liver disease.&#xD;
&#xD;
          -  Known protein C, protein S, or antithrombin deficiency or other known thrombophilic&#xD;
             disorders.&#xD;
&#xD;
          -  Known or suspected pregnancy, women who may become pregnant, and nursing mothers&#xD;
&#xD;
          -  Partial or complete loss of vision due to ophthalmic vascular disease.&#xD;
&#xD;
          -  Uncontrolled hypertension (Systolic blood pressure &gt;160mm Hg and/ or diastolic blood&#xD;
             pressure &gt;95 mm Hg)&#xD;
&#xD;
          -  Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease,&#xD;
             Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal&#xD;
             thyroid stimulating hormone (TSH), it will be corrected in advance of trial&#xD;
             initiation.&#xD;
&#xD;
          -  Active serious suicidal ideation with intent.&#xD;
&#xD;
          -  Regular treatment with a selective serotonin reuptake inhibitor or&#xD;
             serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit&#xD;
&#xD;
          -  Use of other psychoactive or centrally acting medications within 2 weeks before study&#xD;
             screening&#xD;
&#xD;
          -  Known hypersensitivity to either CE or BZA.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Shea, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Healthcare, McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alison Shea, MD</last_name>
    <phone>905-521-2100</phone>
    <phone_ext>33973</phone_ext>
    <email>ashea@stjosham.on.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sophie Vincent, MD</last_name>
    <email>sophie.vincent@medportal.ca</email>
  </overall_contact_backup>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>March 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Alison Shea</investigator_full_name>
    <investigator_title>Menopause and Reproductive Mental Health Specialist</investigator_title>
  </responsible_party>
  <keyword>hormone replacement therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_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/NCT04478305
org study id: 2019-7333
nct id: NCT04478305
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood
      (depression and anxiety) in peri- and early menopausal women.
During the transition to menopause, women are at risk for developing symptoms of depression
      and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in
      this. The investigators suspect that the administration of estrogens without progesterone,
      such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this
      population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada,
      but the effect on mood were not examined closely.

      The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently
      seeking treatment for symptoms of depression or anxiety. The participants will go through a
      round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to
      determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and
      secondarily if treatment with CE/BZA improves their sleep.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group longitudinal study
primary purpose: Treatment
masking: None (Open Label)
measure: Depressive symptoms
time frame: At 4 weeks weeks after beginning study
description: Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 8 weeks after beginning study
description: Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 12 weeks after beginning study
description: Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 16 weeks after beginning study
description: Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 4 weeks after beginning study
description: Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 8 weeks after beginning study
description: Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 12 weeks after beginning study
description: Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.
measure: Depressive symptoms
time frame: At 16 weeks after beginning study
description: Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.
measure: Anxiety symptoms
time frame: At 4 weeks after beginning study
description: Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.
measure: Anxiety symptoms
time frame: At 8 weeks after beginning study
description: Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.
measure: Anxiety symptoms
time frame: At 12 weeks after beginning study
description: Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.
measure: Anxiety symptoms
time frame: At 16 weeks after beginning study
description: Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.
measure: Menopause symptoms
time frame: At 4 weeks after beginning study
description: Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
measure: Menopause symptoms
time frame: At 8 weeks after beginning study
description: Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
measure: Menopause symptoms
time frame: At 12 weeks after beginning study
description: Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
measure: Menopause symptoms
time frame: At 16 weeks after beginning study
description: Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
measure: Total nightly sleep time
time frame: At 4 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Total nightly sleep time
time frame: At 8 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Total nightly sleep time
time frame: At 12 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Total nightly sleep time
time frame: At 16 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Sleep onset latency
time frame: At 4 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Sleep onset latency
time frame: At 8 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Sleep onset latency
time frame: At 12 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Sleep onset latency
time frame: At 16 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Wake after sleep onset
time frame: At 4 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Wake after sleep onset
time frame: At 8 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Wake after sleep onset
time frame: At 12 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
measure: Wake after sleep onset
time frame: At 16 weeks after beginning study
description: Assessed by an Actigraph 2 monitor
arm group label: Intervention group
arm group type: Other
description: Patient will be provided with study medication. To be taken once a day for 16 weeks (112 days). Active drug brand name - Duavive/Duavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.
intervention type: Drug
intervention name: Duavive 0.45Mg-20Mg Tablet
description: Duavee, marketed as Duavive in Canada.
arm group label: Intervention group
other name: Duavive
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: No
last name: Alison Shea, MD
role: Principal Investigator
affiliation: St. Joseph's Healthcare, McMaster University
last name: Alison Shea, MD
phone: 905-521-2100
phone ext: 33973
email: ashea@stjosham.on.ca
last name: Sophie Vincent, MD
email: sophie.vincent@medportal.ca
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Alison Shea
investigator title: Menopause and Reproductive Mental Health Specialist
mesh term: Anxiety Disorders
sharing ipd: No