Depression, Anxiety, Menopause, Menopause Related Conditions, Sleep
Conditions
Keywords
hormone replacement therapy
Brief summary
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
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.
Interventions
DRUGDuavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.
Sponsors
McMaster University
Pfizer
St. Joseph's Healthcare Hamilton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group longitudinal study
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause symptoms | At 4 weeks after beginning study | Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms. |
| Total nightly sleep time | At 4 weeks after beginning study | Assessed by an Actigraph 2 monitor |
| Sleep onset latency | At 4 weeks after beginning study | Assessed by an Actigraph 2 monitor |
| Wake after sleep onset | At 4 weeks after beginning study | Assessed by an Actigraph 2 monitor |
Countries
Canada
Contacts
Primary ContactAlison Shea, MD
Backup ContactLeticia Hernandez Galan, PhD
Outcome results
None listed