Affect of Duavive on Mood & Anxiety Symptoms (DOMA)

St. Joseph's Healthcare Hamilton

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: Duavive 0.45Mg-20Mg Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04478305

2019-7333

Details and patient eligibility

About

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

Full description

During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.

The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.

Enrollment: 30 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention group

Other group

Description:

Patient will be provided with study medication. To be taken once a day for 16 weeks (112 days). Active drug brand name - Duavive/Duavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.

Treatment:

Drug: Duavive 0.45Mg-20Mg Tablet