Affect of Duavive on Mood & Anxiety Symptoms

NCT04478305 | Recruiting Phase 1

• 1 other identifier: 2019-7333
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Depression, Anxiety; Sleep; Menopause Related Conditions

Keywords

hormone replacement therapy

Outcome Measures

Primary Outcomes (12)

• Depressive symptoms

  Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D=10). Any score that is equal to or higher than 10 is considered depressed.

  At 4 weeks weeks after beginning study

• Depressive symptoms

  Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.

  At 8 weeks after beginning study

• Depressive symptoms

  Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.

  At 12 weeks after beginning study

• Depressive symptoms

  Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.

  At 16 weeks after beginning study

• Depressive symptoms

  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.

  At 4 weeks after beginning study

• Depressive symptoms

  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.

  At 8 weeks after beginning study

• Depressive symptoms

  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.

  At 12 weeks after beginning study

• Depressive symptoms

  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.

  At 16 weeks after beginning study

• Anxiety symptoms

  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.

  At 4 weeks after beginning study

• Anxiety symptoms

  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.

  At 8 weeks after beginning study

• Anxiety symptoms

  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.

  At 12 weeks after beginning study

• Anxiety symptoms

  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.

  At 16 weeks after beginning study

Secondary Outcomes (16)

• Menopause symptoms

  At 4 weeks after beginning study

• Menopause symptoms

  At 8 weeks after beginning study

• Menopause symptoms

  At 12 weeks after beginning study

• Menopause symptoms

  At 16 weeks after beginning study

• Total nightly sleep time

  At 4 weeks after beginning study

Study Arms (1)

Intervention group

OTHER

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.

Drug: Duavive 0.45Mg-20Mg Tablet

Interventions

Duavive 0.45Mg-20Mg Tablet DRUG

Duavee, marketed as Duavive in Canada.

Also known as: Duavive

Intervention group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator
• Pfizer: collaborator

Study Sites (1)

St Joseph's Healthcare

Hamilton, Ontario, L8P 3B7, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Alison Shea, MD

  St. Joseph's Healthcare, McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Shea, MD

CONTACT

905-521-2100; ashea@stjosham.on.ca

Leticia Hernandez Galan, PhD

CONTACT

2897001324; lgalan@stjosham.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Menopause and Reproductive Mental Health Specialist

Model Details: Single group longitudinal study

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: July 20, 2020
• Study Start: July 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)