Status:
RECRUITING
Affect of Duavive on Mood & Anxiety Symptoms
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborating Sponsors:
McMaster University
Pfizer
Conditions:
Menopause
Depression, Anxiety
Eligibility:
FEMALE
45-60 years
Phase:
PHASE1
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 investig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04478305
Start Date
July 3 2024
End Date
December 1 2025
Last Update
December 3 2024
Active Locations (1)
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1
St Joseph's Healthcare
Hamilton, Ontario, Canada, L8P 3B7