Affect of Duavive on Mood & Anxiety Symptoms
Recruiting now Phase 1 NCT04478305
Run by St. Joseph's Healthcare Hamilton · for 45 to 60 · Women
What this study 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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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)
🚫 You may not be able to join if…
- 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.
Where this trial is running
- St Joseph's Healthcare, Hamilton, Ontario, Canada
Who to contact
Alison Shea, MD · 905-521-2100 · ashea@stjosham.on.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04478305.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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