Actively Recruiting
The Effect of Conjugated Estrogens/Bazedoxifene on Mood and Anxiety Symptoms in Peri- and Early Postmenopausal Women: A Pilot Study
Led by St. Joseph's Healthcare Hamilton · Updated on 2024-12-03
30
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the effects of conjugated estrogens/bazedoxifene (CE/BZA) on mood, specifically depression and anxiety, in women who are peri- or early postmenopausal. The study focuses on how estrogen fluctuations during menopause might contribute to these symptoms and explores whether treatment with CE/BZA can improve mood and sleep. This is a pilot study involving 30 women seeking treatment for these symptoms. Participants will take a study medication called Duavive, which combines 0.45 mg conjugated estrogens and 20 mg bazedoxifene, once daily for 16 weeks. The study does not involve a placebo or comparison group and lasts for the full 16 weeks of treatment. The goal is to observe changes in mood and sleep during this period. During the study, researchers will regularly assess depressive and anxiety symptoms at 4, 8, 12, and 16 weeks after starting treatment. They will also monitor menopause symptoms and sleep quality, including total sleep time, time to fall asleep, and awakenings after sleep onset. Participants will be closely followed to measure these outcomes and track any changes over the 16 weeks of treatment.
CONDITIONS
Brief 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 within 10 years of final menstrual period
- Experiencing depressive symptoms (score 10 or higher on CES-D-10) and/or anxiety symptoms (score 10 or higher on GAD-7)
You will not qualify if you...
- Personal history of breast, ovarian, or endometrial cancer or endometrial hyperplasia
- Abnormal uterine bleeding not adequately investigated
- Active or past blood clotting events such as deep vein thrombosis, pulmonary embolism, stroke, heart attack, or coronary heart disease
- Active liver disease
- Known protein C, protein S, antithrombin deficiency, or other thrombophilic disorders
- Known or suspected pregnancy, women who may become pregnant, or nursing mothers
- Partial or complete vision loss due to eye vascular disease
- Uncontrolled high blood pressure (systolic >160 mm Hg or diastolic >95 mm Hg)
- Endocrine diseases affecting mood other than thyroid disease
- Active serious suicidal thoughts with intent
- Symptoms of active psychosis
- Daily use of antidepressant medications
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants take Duavive (conjugated estrogens/bazedoxifene) once daily to assess its effect on mood, anxiety, and sleep symptoms.
Visits at 4, 8, 12, and 16 weeks during treatment
Trial Site Locations
Total: 1 location
1
St Joseph's Healthcare
Hamilton, Ontario, Canada, L8P 3B7
Actively Recruiting
Research Team
A
Alison Shea, MD
L
Leticia Hernandez Galan, PhD
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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