Actively Recruiting
Affect of Duavive on Mood & Anxiety Symptoms
Led by St. Joseph's Healthcare Hamilton · Updated on 2024-12-03
30
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
S
St. Joseph's Healthcare Hamilton
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
CONDITIONS
Official Title
Affect of Duavive on Mood & Anxiety Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female between 45 and 60 years old
- Able to communicate in English
- In perimenopause as defined by WHO STRAW criteria or in early menopause within 10 years of final menstrual period
- Experiencing depressive symptoms (score of 10 or higher on CES-D-10) and/or anxiety symptoms (score of 10 or higher on GAD-7)
You will not qualify if you...
- Personal history of breast, ovarian, or endometrial cancer or endometrial hyperplasia
- Unexplained abnormal uterine bleeding
- Active or past venous or arterial blood clots such as deep vein thrombosis, pulmonary embolism, stroke, heart attack, or coronary heart disease
- Active liver disease
- Known clotting disorders like protein C, protein S, or antithrombin deficiency
- Known or suspected pregnancy, women who may become pregnant, or nursing mothers
- Partial or complete vision loss due to eye blood vessel disease
- Uncontrolled high blood pressure (systolic >160 mm Hg or diastolic >95 mm Hg)
- Endocrine diseases affecting mood (excluding thyroid disease)
- Active serious suicidal thoughts with intent
- Symptoms of active psychosis
- Daily use of antidepressant medication
- Use of other psychoactive or central nervous system medications within 2 weeks before screening
- Known allergy to conjugated estrogens or bazedoxifene
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St Joseph's Healthcare
Hamilton, Ontario, Canada, L8P 3B7
Actively Recruiting
Research Team
A
Alison Shea, MD
CONTACT
L
Leticia Hernandez Galan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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