RecruitingPhase 1NCT04478305

Affect of Duavive on Mood & Anxiety Symptoms

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

Sponsor

St. Joseph's Healthcare Hamilton

Enrollment

30 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

Menopause Depression, Anxiety Sleep Menopause Related Conditions

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

Sex: FEMALEMin Age: 45 YearsMax Age: 60 Years

Inclusion Criteria4

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 Criteria14

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.