MenopauseDepression, AnxietySleepMenopause Related Conditions
Investigational drug(s) / intervention(s)
Duavive 0.45Mg-20Mg Tablet
Duavive 0.45Mg-20Mg Tablet: Duavee, marketed as Duavive in Canada.
Study summary
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
Eligibility
Sex
FEMALE
Min age
45 Years
Max age
60 Years
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 (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.
Primary outcome measure(s)
Depressive symptoms — At 4 weeks weeks after beginning study 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Trial sites (1)
Facility
City
Region
Status
St Joseph's Healthcare
Hamilton
Ontario
Recruiting
More St. Joseph's Healthcare Hamilton trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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