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Affect of Duavive on Mood & Anxiety Symptoms (DOMA)

Primary Purpose

Menopause, Depression, Anxiety, Sleep

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Duavive 0.45Mg-20Mg Tablet
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring hormone replacement therapy

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females between 45-60 years of age
  • Able to communicate in English
  • In perimenopause as defined by World Health Organization (WHO) STages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)
  • Suffering from Depressive symptoms (16+ on CES-D) AND/OR anxiety symptoms (10+ on GAD-7)

Exclusion Criteria:

  • Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.
  • Abnormal uterine bleeding that has not been adequately investigated.
  • Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).
  • Active liver disease.
  • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
  • Known or suspected pregnancy, women who may become pregnant, and nursing mothers
  • Partial or complete loss of vision due to ophthalmic vascular disease.
  • Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood pressure >95 mm Hg)
  • Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease, Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal thyroid stimulating hormone (TSH), it will be corrected in advance of trial initiation.
  • Active serious suicidal ideation with intent.
  • Regular treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit
  • Use of other psychoactive or centrally acting medications within 2 weeks before study screening
  • Known hypersensitivity to either CE or BZA.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Intervention group

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Depressive symptoms
    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.
    Anxiety symptoms
    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.
    Anxiety symptoms
    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.
    Anxiety symptoms
    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.
    Anxiety symptoms
    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.

    Secondary Outcome Measures

    Menopause symptoms
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Menopause symptoms
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Menopause symptoms
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Menopause symptoms
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Total nightly sleep time
    Assessed by an Actigraph 2 monitor
    Total nightly sleep time
    Assessed by an Actigraph 2 monitor
    Total nightly sleep time
    Assessed by an Actigraph 2 monitor
    Total nightly sleep time
    Assessed by an Actigraph 2 monitor
    Sleep onset latency
    Assessed by an Actigraph 2 monitor
    Sleep onset latency
    Assessed by an Actigraph 2 monitor
    Sleep onset latency
    Assessed by an Actigraph 2 monitor
    Sleep onset latency
    Assessed by an Actigraph 2 monitor
    Wake after sleep onset
    Assessed by an Actigraph 2 monitor
    Wake after sleep onset
    Assessed by an Actigraph 2 monitor
    Wake after sleep onset
    Assessed by an Actigraph 2 monitor
    Wake after sleep onset
    Assessed by an Actigraph 2 monitor

    Full Information

    First Posted
    March 19, 2020
    Last Updated
    October 21, 2020
    Sponsor
    St. Joseph's Healthcare Hamilton
    Collaborators
    McMaster University, Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04478305
    Brief Title
    Affect of Duavive on Mood & Anxiety Symptoms
    Acronym
    DOMA
    Official Title
    The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Healthcare Hamilton
    Collaborators
    McMaster University, Pfizer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menopause, Depression, Anxiety, Sleep
    Keywords
    hormone replacement therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single group longitudinal study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Other
    Arm 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(s)
    Duavive 0.45Mg-20Mg Tablet
    Other Intervention Name(s)
    Duavive
    Intervention Description
    Duavee, marketed as Duavive in Canada.
    Primary Outcome Measure Information:
    Title
    Depressive symptoms
    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.
    Time Frame
    At 4 weeks weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 8 weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 12 weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 16 weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 4 weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 8 weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 12 weeks after beginning study
    Title
    Depressive symptoms
    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.
    Time Frame
    At 16 weeks after beginning study
    Title
    Anxiety symptoms
    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.
    Time Frame
    At 4 weeks after beginning study
    Title
    Anxiety symptoms
    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.
    Time Frame
    At 8 weeks after beginning study
    Title
    Anxiety symptoms
    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.
    Time Frame
    At 12 weeks after beginning study
    Title
    Anxiety symptoms
    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.
    Time Frame
    At 16 weeks after beginning study
    Secondary Outcome Measure Information:
    Title
    Menopause symptoms
    Description
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Time Frame
    At 4 weeks after beginning study
    Title
    Menopause symptoms
    Description
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Time Frame
    At 8 weeks after beginning study
    Title
    Menopause symptoms
    Description
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Time Frame
    At 12 weeks after beginning study
    Title
    Menopause symptoms
    Description
    Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
    Time Frame
    At 16 weeks after beginning study
    Title
    Total nightly sleep time
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 4 weeks after beginning study
    Title
    Total nightly sleep time
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 8 weeks after beginning study
    Title
    Total nightly sleep time
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 12 weeks after beginning study
    Title
    Total nightly sleep time
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 16 weeks after beginning study
    Title
    Sleep onset latency
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 4 weeks after beginning study
    Title
    Sleep onset latency
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 8 weeks after beginning study
    Title
    Sleep onset latency
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 12 weeks after beginning study
    Title
    Sleep onset latency
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 16 weeks after beginning study
    Title
    Wake after sleep onset
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 4 weeks after beginning study
    Title
    Wake after sleep onset
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 8 weeks after beginning study
    Title
    Wake after sleep onset
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 12 weeks after beginning study
    Title
    Wake after sleep onset
    Description
    Assessed by an Actigraph 2 monitor
    Time Frame
    At 16 weeks after beginning study

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females between 45-60 years of age Able to communicate in English In perimenopause as defined by World Health Organization (WHO) STages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period) Suffering from Depressive symptoms (16+ on CES-D) AND/OR anxiety symptoms (10+ on GAD-7) Exclusion Criteria: Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia. Abnormal uterine bleeding that has not been adequately investigated. Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease). Active liver disease. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Known or suspected pregnancy, women who may become pregnant, and nursing mothers Partial or complete loss of vision due to ophthalmic vascular disease. Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood pressure >95 mm Hg) Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease, Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal thyroid stimulating hormone (TSH), it will be corrected in advance of trial initiation. Active serious suicidal ideation with intent. Regular treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit Use of other psychoactive or centrally acting medications within 2 weeks before study screening Known hypersensitivity to either CE or BZA.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alison Shea, MD
    Phone
    905-521-2100
    Ext
    33973
    Email
    ashea@stjosham.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sophie Vincent, MD
    Email
    sophie.vincent@medportal.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alison Shea, MD
    Organizational Affiliation
    St. Joseph's Healthcare, McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Affect of Duavive on Mood & Anxiety Symptoms

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