NCT04478305 Affect of Duavive on Mood & Anxiety Symptoms
| NCT ID | NCT04478305 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Joseph's Healthcare Hamilton |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-07-03 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Alison Shea, MD
PRINCIPAL INVESTIGATOR
St. Joseph's Healthcare, McMaster University
Frequently Asked Questions
Who can join the NCT04478305 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 60 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04478305 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04478305 currently recruiting?
Yes, NCT04478305 is actively recruiting participants. Contact the research team at ashea@stjosham.on.ca for enrollment information.
Where is the NCT04478305 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT04478305 clinical trial?
NCT04478305 is sponsored by St. Joseph's Healthcare Hamilton. The principal investigator is Alison Shea, MD at St. Joseph's Healthcare, McMaster University. The trial plans to enroll 30 participants.