Affect of Duavive on Mood & Anxiety Symptoms

Recruiting now · Phase 1

Conditions studied: Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions

In brief

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

Key facts

Study ID

NCT04478305

Run by

St. Joseph's Healthcare Hamilton

People needed

30

Starts

2024-07-03

Expected to finish

2025-12-01

Last updated by the study team

2024-12-03

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• St Joseph's Healthcare — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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