Affect of Duavive on Mood & Anxiety Symptoms

Phase 1

Recruiting

• Conditions: Menopause; Depression, Anxiety; Sleep; Menopause Related Conditions
• Interventions: Drug: Duavive 0.45Mg-20Mg Tablet

• Registration Number: NCT04478305
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Study Start: 2024-07-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Duavive 0.45Mg-20Mg Tablet	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.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	At 16 weeks after beginning study	Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.
Anxiety symptoms	At 16 weeks after beginning study	Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.

Secondary Outcome Measures

Name	Time	Method
Total nightly sleep time	At 16 weeks after beginning study	Assessed by an Actigraph 2 monitor
Sleep onset latency	At 16 weeks after beginning study	Assessed by an Actigraph 2 monitor
Menopause symptoms	At 16 weeks after beginning study	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Wake after sleep onset	At 16 weeks after beginning study	Assessed by an Actigraph 2 monitor

Trial Locations

Locations (1)

St Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada