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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04478305
Other study ID # 2019-7333
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date March 2021
Est. completion date September 2021

Study information

Verified date October 2020
Source St. Joseph's Healthcare Hamilton
Contact Alison Shea, MD
Phone 905-521-2100
Email ashea@stjosham.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton McMaster University, Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Total nightly sleep time Assessed by an Actigraph 2 monitor At 4 weeks after beginning study
Secondary Total nightly sleep time Assessed by an Actigraph 2 monitor At 8 weeks after beginning study
Secondary Total nightly sleep time Assessed by an Actigraph 2 monitor At 12 weeks after beginning study
Secondary Total nightly sleep time Assessed by an Actigraph 2 monitor At 16 weeks after beginning study
Secondary Sleep onset latency Assessed by an Actigraph 2 monitor At 4 weeks after beginning study
Secondary Sleep onset latency Assessed by an Actigraph 2 monitor At 8 weeks after beginning study
Secondary Sleep onset latency Assessed by an Actigraph 2 monitor At 12 weeks after beginning study
Secondary Sleep onset latency Assessed by an Actigraph 2 monitor At 16 weeks after beginning study
Secondary Wake after sleep onset Assessed by an Actigraph 2 monitor At 4 weeks after beginning study
Secondary Wake after sleep onset Assessed by an Actigraph 2 monitor At 8 weeks after beginning study
Secondary Wake after sleep onset Assessed by an Actigraph 2 monitor At 12 weeks after beginning study
Secondary Wake after sleep onset Assessed by an Actigraph 2 monitor At 16 weeks after beginning study
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