Plain-English translation of NCT04478305 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This is a pilot study testing whether conjugated estrogens/bazedoxifene (a hormone medication) can help improve mood and anxiety symptoms in women going through or recently finished menopause. The medication was already approved to treat hot flashes, but researchers want to see if it also helps with depression and anxiety, which are common during this life stage. You would take one pill daily for 16 weeks and complete assessments to measure any changes in your mood and sleep.
During menopause, fluctuating hormone levels can trigger depression, anxiety, and sleep problems in many women. While this treatment is already available for hot flashes, doctors haven't carefully studied whether it also helps with mood symptoms—so this research aims to fill that gap.
You likely qualify if…
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You would take one pill of this medication by mouth each day for 16 weeks (about 4 months). During the study, you'll likely have a few appointments to check in, answer questions about your mood and anxiety, and discuss how you're feeling. Researchers will measure whether the medication helps reduce your depression and anxiety symptoms and improves your sleep using standard questionnaires.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
Canada
Phase
Safety & dosing
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University, Pfizer
Enrollment target
~30 participants
Started
July 2024
Primary completion
December 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
45 Years – 60 Years
Sex
Female only
Last updated on clinicaltrials.gov in December 2024.
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Central contact
Alison Shea, MD
St. Joseph's Healthcare, McMaster University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.