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| Name | Class |
|---|---|
| McMaster University | OTHER |
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duavive 0.45Mg-20Mg Tablet | Drug | Duavee, marketed as Duavive in Canada. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Shea, MD | Contact | 905-521-2100 | 33973 | ashea@stjosham.on.ca |
| Leticia Hernandez Galan, PhD | Contact | 2897001324 | lgalan@stjosham.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Alison Shea, MD | St. Joseph's Healthcare, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare | Recruiting | Hamilton | Ontario | L8P 3B7 | Canada |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Single group longitudinal study
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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 |
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 |