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Hormone Therapy

Duavive for Menopausal Depression (DOMA Trial)

Phase 1

Recruiting

Led By Alison Shea, MD

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females between 45-60 years of age

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)

Must not have

Daily use of antidepressive medication

Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 16 weeks after beginning study

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

"This trial looks at how a specific medication, conjugated estrogens/ bazedoxifene (CE/ BZA), affects the mood of women going through menopause, specifically looking at depression

Who is the study for?

This trial is for English-speaking women aged 45-60 who are in perimenopause or early menopause (within 10 years of their last period) and experiencing depression (scoring 16+ on CES-D) or anxiety symptoms (scoring 10+ on GAD-7).

What is being tested?

The study tests the effects of Duavive, a tablet combining conjugated estrogens with bazedoxifene, on mood swings related to depression and anxiety in peri- and early postmenopausal women.

What are the potential side effects?

Possible side effects may include typical estrogen-related reactions such as nausea, headaches, breast tenderness, and blood clots. Mood changes could also occur due to hormonal fluctuations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 45 and 60.

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I am in perimenopause or within 10 years of my last menstrual period.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take antidepressant medication every day.

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I have a history of breast, ovarian, endometrial cancer, or endometrial hyperplasia.

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I have had blood clots or heart-related issues in the past.

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I have an ongoing liver condition.

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I have a known blood clotting disorder.

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I have lost some or all of my vision due to an eye blood vessel condition.

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I am experiencing symptoms of psychosis.

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I am currently experiencing serious thoughts of suicide with a plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 16 weeks after beginning study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 16 weeks after beginning study

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 16 weeks after beginning study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety symptoms

Depressive symptoms

Secondary study objectives

Menopause symptoms

Sleep Onset Latency

Total nightly sleep time

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention groupExperimental Treatment1 Intervention

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.

0 / 10Eligibility criteria met