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DOMA: Affect of Duavive on Mood & Anxiety Symptoms

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04478305
Collaborator
McMaster University (Other), Pfizer (Industry)
30
Enrollment
1
Arm
6
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Duavive 0.45Mg-20Mg Tablet
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group longitudinal studySingle group longitudinal study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention group

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.

Drug: Duavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.
Other Names:
  • Duavive

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Depressive symptoms [At 4 weeks weeks after beginning study]

      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.

    2. Depressive symptoms [At 8 weeks after beginning study]

      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.

    3. Depressive symptoms [At 12 weeks after beginning study]

      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.

    4. Depressive symptoms [At 16 weeks after beginning study]

      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.

    5. Depressive symptoms [At 4 weeks after beginning study]

      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.

    6. Depressive symptoms [At 8 weeks after beginning study]

      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.

    7. Depressive symptoms [At 12 weeks after beginning study]

      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.

    8. Depressive symptoms [At 16 weeks after beginning study]

      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.

    9. Anxiety symptoms [At 4 weeks after beginning study]

      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.

    10. Anxiety symptoms [At 8 weeks after beginning study]

      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.

    11. Anxiety symptoms [At 12 weeks after beginning study]

      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.

    12. Anxiety symptoms [At 16 weeks after beginning study]

      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

    1. Menopause symptoms [At 4 weeks after beginning study]

      Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

    2. Menopause symptoms [At 8 weeks after beginning study]

      Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

    3. Menopause symptoms [At 12 weeks after beginning study]

      Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

    4. Menopause symptoms [At 16 weeks after beginning study]

      Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

    5. Total nightly sleep time [At 4 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    6. Total nightly sleep time [At 8 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    7. Total nightly sleep time [At 12 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    8. Total nightly sleep time [At 16 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    9. Sleep onset latency [At 4 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    10. Sleep onset latency [At 8 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    11. Sleep onset latency [At 12 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    12. Sleep onset latency [At 16 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    13. Wake after sleep onset [At 4 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    14. Wake after sleep onset [At 8 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    15. Wake after sleep onset [At 12 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    16. Wake after sleep onset [At 16 weeks after beginning study]

      Assessed by an Actigraph 2 monitor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • St. Joseph's Healthcare Hamilton
    • McMaster University
    • Pfizer

    Investigators

    • Principal Investigator: Alison Shea, MD, St. Joseph's Healthcare, McMaster University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alison Shea, Menopause and Reproductive Mental Health Specialist, St. Joseph's Healthcare Hamilton
    ClinicalTrials.gov Identifier:
    NCT04478305
    Other Study ID Numbers:
    • 2019-7333
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Alison Shea, Menopause and Reproductive Mental Health Specialist, St. Joseph's Healthcare Hamilton
    hormone replacement therapy
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Oct 22, 2020