30 Participants Needed

Duavive for Menopausal Depression

(DOMA Trial)

AS
SV
LH
Overseen ByLeticia Hernandez Galan, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

If you are taking antidepressants or other psychoactive medications, you will need to stop them at least 2 weeks before the study starts.

What data supports the effectiveness of the drug Duavive for menopausal depression?

There is evidence that estrogen therapy, a component of Duavive, has antidepressant effects in perimenopausal women, especially those with hot flashes and other menopause symptoms. However, data on estrogen combined with other components like progestin are limited and not conclusive.12345

Is Duavive safe for humans?

Duavive (also known as bazedoxifene/conjugated estrogens) has been shown to be generally safe in humans, with studies indicating no significant differences in serious health events like heart or stroke issues compared to other treatments. However, some side effects like hot flashes and leg cramps were more common than with a placebo.678910

How is the drug Duavive unique for treating menopausal depression?

Duavive is unique because it combines conjugated estrogens with bazedoxifene, which acts as a selective estrogen receptor modulator (SERM) to help manage menopausal symptoms and potentially improve mood. This combination may offer a novel approach compared to traditional antidepressants or hormone therapies used separately.1351112

Research Team

AS

Alison Shea, MD

Principal Investigator

St. Joseph's Healthcare, McMaster University

Eligibility Criteria

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).

Inclusion Criteria

Able to communicate in English
I am a woman aged between 45 and 60.
I am in perimenopause or within 10 years of my last menstrual period.
See 1 more

Exclusion Criteria

Known or suspected pregnancy, women who may become pregnant, and nursing mothers
Known hypersensitivity to either CE or BZA
Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood pressure >95 mm Hg)
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CE/BZA treatment for mood and anxiety symptoms

16 weeks
Daily medication intake

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Duavive
Trial Overview 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.
Participant Groups
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.

Duavive is already approved in European Union, United States for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Duavive for:
  • Treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus
πŸ‡ΊπŸ‡Έ
Approved in United States as Duavee for:
  • Treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

McMaster University

Collaborator

Trials
936
Recruited
2,630,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

In a randomized, double-blind, placebo-controlled trial involving 387 perimenopausal and postmenopausal women, desvenlafaxine significantly reduced depression scores compared to placebo over 8 weeks, with a notable effect seen as early as week 1.
Desvenlafaxine treatment resulted in higher response (58.6%) and remission (38.2%) rates compared to placebo (31.6% and 22.4%, respectively), indicating its efficacy in treating major depressive disorder in this population, while it was generally well tolerated despite a higher rate of treatment-emergent adverse events.
Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.Kornstein, SG., Jiang, Q., Reddy, S., et al.[2015]
In a study of menopausal women receiving hormone replacement therapy with conjugated oestrogens (Premarin) over four weeks, non-depressed women showed improved depression scores and increased feelings of well-being.
However, the depressed group did not experience any improvement in their depression levels, suggesting that hormone replacement therapy may not be effective for alleviating depression in women who are already depressed.
The effect of exogenous oestrogens on depression in menopausal women.Schneider, MA., Brotherton, PL., Hailes, J.[2021]
Desvenlafaxine significantly reduced depression scores in both perimenopausal and postmenopausal women with major depressive disorder, showing a notable improvement compared to placebo after 8 weeks of treatment.
The study included 798 women, and desvenlafaxine also led to significant improvements in disability and menopause-related symptoms, indicating its efficacy beyond just mood enhancement.
A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women.Kornstein, SG., Clayton, AH., Bao, W., et al.[2015]

References

Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. [2015]
The effect of exogenous oestrogens on depression in menopausal women. [2021]
A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. [2015]
Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations. [2019]
Effects of synthetic and plant-derived selective modulators of estrogen receptors on depression-like behavior of female rats. [2019]
Cardiovascular safety of conjugated estrogens plus bazedoxifene: meta-analysis of the SMART trials. [2015]
Effects of bazedoxifene/conjugated estrogens on endometrial safety and bone in postmenopausal women. [2013]
Bazedoxifene (Wyeth). [2022]
Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. [2022]
[Bazedoxifene as a new-generation SERM]. [2012]
[Climacteric depression and anxiety]. [2021]
Tamoxifen antagonizes the effects of ovarian hormones to induce anxiety and depression-like behavior in rats. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security