Affect of Duavive on Mood & Anxiety Symptoms

• Status: Not yet recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: McMaster University; Pfizer

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 (16+ on CES-D) 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)

• Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease, Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal thyroid stimulating hormone (TSH), it will be corrected in advance of trial initiation.

• Active serious suicidal ideation with intent.

• Regular treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit

• Use of other psychoactive or centrally acting medications within 2 weeks before study screening

• Known hypersensitivity to either CE or BZA.