What is Duavive studying for menopause-related mood symptoms?

Duavive is being studied to see if it can improve mood symptoms like depression and anxiety during peri- and early postmenopause. Researchers want to understand how this treatment might affect mood and sleep in women experiencing menopause-related changes. This study is sponsored by St. Joseph's Healthcare Hamilton.

Who may be eligible for this menopause clinical trial?

Women aged 45 to 60 years who are in perimenopause or early menopause and experiencing symptoms of depression or anxiety may be eligible. Only females can participate. Certain health conditions, such as a history of specific cancers or blood clots, may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this menopause clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants should consider potential travel costs when joining the trial.

Actively Recruiting

Phase 1

Age: 45Years - 60Years

FEMALE

ID04478305

Pilot Study of Duavive Conjugated EstrogensBazedoxifene to Improve Mood and Anxiety in Women Aged 45 to 60 During Menopause Transition

Led by St. Joseph's Healthcare Hamilton · Updated on 2024-12-03

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of conjugated estrogensbazedoxifene CEBZA on mood, specifically depression and anxiety, in women who are peri- or early postmenopausal. The study focuses on how estrogen fluctuations during menopause might contribute to these symptoms and explores whether treatment with CEBZA can improve mood and sleep. This is a pilot study involving 30 women seeking treatment for these symptoms. Participants will take a study medication called Duavive, which combines 0.45 mg conjugated estrogens and 20 mg bazedoxifene, once daily for 16 weeks. The study does not involve a placebo or comparison group and lasts for the full 16 weeks of treatment. The goal is to observe changes in mood and sleep during this period. During the study, researchers will regularly assess depressive and anxiety symptoms at 4, 8, 12, and 16 weeks after starting treatment. They will also monitor menopause symptoms and sleep quality, including total sleep time, time to fall asleep, and awakenings after sleep onset. Participants will be closely followed to measure these outcomes and track any changes over the 16 weeks of treatment.

CONDITIONS

Brief Title

Affect of Duavive on Mood & Anxiety Symptoms

Who Can Participate

Age: 45Years - 60Years

FEMALE

Eligibility Criteria

You may qualify if you...

Female between 45 and 60 years old
Able to communicate in English
In perimenopause as defined by WHO STRAW criteria, or within 10 years of final menstrual period
Experiencing depressive symptoms (score 10 or higher on CES-D-10) and/or anxiety symptoms (score 10 or higher on GAD-7)

You will not qualify if you...

Personal history of breast, ovarian, or endometrial cancer or endometrial hyperplasia
Abnormal uterine bleeding not adequately investigated
Active or past blood clotting events such as deep vein thrombosis, pulmonary embolism, stroke, heart attack, or coronary heart disease
Active liver disease
Known protein C, protein S, antithrombin deficiency, or other thrombophilic disorders
Known or suspected pregnancy, women who may become pregnant, or nursing mothers
Partial or complete vision loss due to eye vascular disease
Uncontrolled high blood pressure (systolic >160 mm Hg or diastolic >95 mm Hg)
Endocrine diseases affecting mood other than thyroid disease
Active serious suicidal thoughts with intent
Symptoms of active psychosis
Daily use of antidepressant medications
Use of other psychoactive or central nervous system medications within 2 weeks before screening
Known allergy to conjugated estrogens or bazedoxifene

Research Team

Alison Shea, MD

Leticia Hernandez Galan, PhD

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Pilot Study of Duavive Conjugated EstrogensBazedoxifene to Improve Mood and Anxiety in Women Aged 45 to 60 During Menopause Transition

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria