Affect of Duavive on Mood & Anxiety Symptoms (DOMA)

The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study

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

Study Overview

• Status: Recruiting
• Conditions: Sleep; Menopause; Depression, Anxiety; Menopause Related Conditions
• Intervention / Treatment: Drug: Duavive 0.45Mg-20Mg Tablet

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alison Shea, MD; Phone Number: 33973 905-521-2100; Email: ashea@stjosham.on.ca
• Study Contact Backup: Name: Leticia Hernandez Galan, PhD; Phone Number: 2897001324; Email: lgalan@stjosham.on.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P 3B7
      • Recruiting
      • St Joseph's Healthcare
      • Contact: Leticia Hernandez Galan, PhD; Phone Number: 2897001324; Email: lgalan@stjosham.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 (10+ on CES-D-10) 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)
• Endocrine disease (other than thyroid disease) that may adversely affect mood (i.e., Cushing's disease, Addison's disease). For women with abnormal TSH, it will be corrected in advance of trial initiation.
• Active serious suicidal ideation with intent.
• Symptoms of active psychosis.
• Daily use of antidepressive medication.
• Use of other psychoactive or centrally acting medications within 2 weeks before study screening.
• Known hypersensitivity to either CE or BZA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 8 weeks after beginning study
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.	At 12 weeks after beginning study
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.	At 16 weeks after beginning study
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.	At 4 weeks after beginning study
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.	At 8 weeks after beginning study
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.	At 12 weeks after beginning study
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.	At 16 weeks after beginning study
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.	At 4 weeks after beginning study
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.	At 8 weeks after beginning study
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.	At 12 weeks after beginning study
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.	At 16 weeks after beginning study
Depressive symptoms	Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D=10). Any score that is equal to or higher than 10 is considered depressed.	At 4 weeks weeks after beginning study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 4 weeks after beginning study
Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 8 weeks after beginning study
Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 12 weeks after beginning study
Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 16 weeks after beginning study
Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 4 weeks after beginning study
Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 8 weeks after beginning study
Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 12 weeks after beginning study
Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 16 weeks after beginning study
Sleep onset latency	Assessed by an Actigraph 2 monitor	At 4 weeks after beginning study
Sleep onset latency	Assessed by an Actigraph 2 monitor	At 8 weeks after beginning study
Sleep onset latency	Assessed by an Actigraph 2 monitor	At 12 weeks after beginning study
Sleep onset latency	Assessed by an Actigraph 2 monitor	At 16 weeks after beginning study
Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 4 weeks after beginning study
Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 8 weeks after beginning study
Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 12 weeks after beginning study
Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 16 weeks after beginning study

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Pfizer; McMaster University
• Investigators: Principal Investigator: Alison Shea, MD, St. Joseph's Healthcare, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hormone replacement therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019-7333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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