Recruiting

Affect of Duavive on Mood & Anxiety Symptoms

This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

ClinicalTrials.gov IDNCT04478305
PhasePHASE1
Enrollment30
SponsorSt. Joseph's Healthcare Hamilton
Age45 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions

About this study

This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.