Duavive for Menopausal Depression
(DOMA Trial)
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CE/BZA treatment for mood and anxiety symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Duavive
Duavive is already approved in European Union, United States for the following indications:
- Treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus
- 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
McMaster University
Collaborator
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University