Impact of Duavive on mood and anxiety in menopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of conjugated estrogens/bazedoxifene (CE/BZA) on mood symptoms, specifically depression and anxiety, in peri- and early menopausal women. The research aims to determine if CE/BZA can improve mood and sleep quality in this population, who are at risk for mood disorders due to hormonal fluctuations during menopause. The pilot study will involve 30 participants undergoing a 16-week treatment regimen with CE/BZA, focusing on their mental health outcomes. The study is significant as it explores a treatment option that has not been thoroughly investigated for mood-related symptoms in menopausal women.

Why it matters

Who can join: the full rules

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.

Where it's running

• St Joseph's Healthcare
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Alison Shea, MD — St. Joseph's Healthcare, McMaster University
• Study coordinator: Alison Shea, MD
• Email: ashea@stjosham.on.ca
• Phone: 905-521-2100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.