Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2024-07-03
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention group
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.
Duavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.
Interventions
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Duavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
60 Years
FEMALE
No
Sponsors
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McMaster University
OTHER
Pfizer
INDUSTRY
St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Alison Shea
Menopause and Reproductive Mental Health Specialist
Principal Investigators
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Alison Shea, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare, McMaster University
Locations
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St Joseph's Healthcare
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-7333
Identifier Type: -
Identifier Source: org_study_id