Affect of Duavive on Mood & Anxiety Symptoms

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Menopause, Depression, Anxiety, Sleep

Intervention / Treatment
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* Drug: Duavive 0.45Mg-20Mg Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group longitudinal study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>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<br>* Duavee, marketed as Duavive in Canada.<br>* Other names: Duavive;|

What is the study measuring?
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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 4 weeks 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 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hormone replacement therapy