RecruitingPhase 1

Affect of Duavive on Mood & Anxiety Symptoms

Canada30 participantsStarted 2024-07-03

Plain-language summary

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 participate

Age range

45 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 be…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Depressive symptoms

Timeframe: At 4 weeks weeks after beginning study

Depressive symptoms

Timeframe: At 8 weeks after beginning study

Depressive symptoms

Timeframe: At 12 weeks after beginning study

Depressive symptoms

Timeframe: At 16 weeks after beginning study

Depressive symptoms

Timeframe: At 4 weeks after beginning study

Depressive symptoms

Timeframe: At 8 weeks after beginning study

Depressive symptoms

Timeframe: At 12 weeks after beginning study

Depressive symptoms

Timeframe: At 16 weeks after beginning study

Trial details

NCT IDNCT04478305

SponsorSt. Joseph's Healthcare Hamilton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Alison Shea, MD

905-521-2100 ashea@stjosham.on.ca

View on ClinicalTrials.gov More Menopause trials

Who can participate

Age range

45 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Depressive symptoms

Timeframe: At 4 weeks weeks after beginning study

Depressive symptoms

Timeframe: At 8 weeks after beginning study

Depressive symptoms

Timeframe: At 12 weeks after beginning study

Depressive symptoms

Timeframe: At 16 weeks after beginning study

Depressive symptoms

Timeframe: At 4 weeks after beginning study

Depressive symptoms

Timeframe: At 8 weeks after beginning study

Depressive symptoms

Timeframe: At 12 weeks after beginning study

Depressive symptoms

Timeframe: At 16 weeks after beginning study