Impact of Duavive on mood and anxiety in menopausal women

The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study

This study is testing if a new hormone treatment can help improve mood and reduce anxiety in women going through menopause.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 45 Years to 60 Years
• Sex: Female
• Sponsor: St. Joseph's Healthcare Hamilton (other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT04478305 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are females aged 45-60 who are in perimenopause or early menopause and experiencing depressive or anxiety symptoms.

Not a fit: Patients with a history of certain cancers, thromboembolic diseases, or other specified medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve mood and anxiety symptoms in peri- and early menopausal women.

How similar studies have performed: While CE/BZA has been approved for menopausal vasomotor symptoms, its effects on mood have not been extensively studied, making this approach relatively novel.

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.

Where this trial is running

Hamilton, Ontario

• 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

Conditions: Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions, hormone replacement therapy