MenopausePhase 1DOMANCT04478305
Affect of Duavive on Mood & Anxiety Symptoms
A Phase 1 study testing Duavive 0.45Mg-20Mg Tablet in people with Menopause and Depression, Anxiety, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause, Depression, Anxiety, Sleep
- What is being tested?
- Duavive 0.45Mg-20Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2024to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St Joseph's Healthcare
Hamilton, Ontario, L8P 3B7
Leticia Hernandez Galan, PhD, 2897001324, lgalan@stjosham.on.ca
About this study
Official title: The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
Read the detailed description
During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.
The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.
- Conditions
- Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions
- Being tested
- Duavive 0.45Mg-20Mg Tablet
- Keywords
- hormone replacement therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duavive 0.45Mg-20Mg TabletDrug
Also called Duavive
Duavee, marketed as Duavive in Canada.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duavive 0.45Mg-20Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 16 weeks after beginning study
Secondary outcomes (16)
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Measured: At 4 weeks after beginning study
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Measured: At 8 weeks after beginning study
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Measured: At 12 weeks after beginning study
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Measured: At 16 weeks after beginning study
Total nightly sleep time
Assessed by an Actigraph 2 monitor
Measured: At 4 weeks after beginning study
Total nightly sleep time
Assessed by an Actigraph 2 monitor
Measured: At 8 weeks after beginning study
Total nightly sleep time
Assessed by an Actigraph 2 monitor
Measured: At 12 weeks after beginning study
Total nightly sleep time
Assessed by an Actigraph 2 monitor
Measured: At 16 weeks after beginning study
Sleep onset latency
Assessed by an Actigraph 2 monitor
Measured: At 4 weeks after beginning study
Sleep onset latency
Assessed by an Actigraph 2 monitor
Measured: At 8 weeks after beginning study
Sleep onset latency
Assessed by an Actigraph 2 monitor
Measured: At 12 weeks after beginning study
Sleep onset latency
Assessed by an Actigraph 2 monitor
Measured: At 16 weeks after beginning study
Wake after sleep onset
Assessed by an Actigraph 2 monitor
Measured: At 4 weeks after beginning study
Wake after sleep onset
Assessed by an Actigraph 2 monitor
Measured: At 8 weeks after beginning study
Wake after sleep onset
Assessed by an Actigraph 2 monitor
Measured: At 12 weeks after beginning study
Wake after sleep onset
Assessed by an Actigraph 2 monitor
Measured: At 16 weeks after beginning study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start3 Jul 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group longitudinal study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Pfizer
- Responsible party
- Principal investigator, Alison Shea, St. Joseph's Healthcare Hamilton
- Investigators
- Alison Shea, MD, Principal investigator, St. Joseph's Healthcare, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478305
- Sponsor's protocol ID
- 2019-7333
- Acronym
- DOMA
- Status last verified
- Nov 2024
- First submitted
- 19 Mar 2020
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
- ClinicalTrials.gov ID
- NCT04478305
- Acronym / sponsor ID
- DOMA / 2019-7333
- Conditions
- Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions
- Keywords
- hormone replacement therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University, Pfizer
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
Detailed description
During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.
The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Drug: Duavive 0.45Mg-20Mg TabletPatient 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duavive 0.45Mg-20Mg TabletAlso: DuaviveDuavee, marketed as Duavive in Canada. | Drug | Intervention group |
Primary outcome
Depressive symptoms
Time frame: At 4 weeks weeks after beginning study
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.
Depressive symptoms
Time frame: At 8 weeks after beginning study
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.
Depressive symptoms
Time frame: At 12 weeks after beginning study
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.
Depressive symptoms
Time frame: At 16 weeks after beginning study
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.
Depressive symptoms
Time frame: At 4 weeks after beginning study
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.
Depressive symptoms
Time frame: At 8 weeks after beginning study
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.
Depressive symptoms
Time frame: At 12 weeks after beginning study
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.
Depressive symptoms
Time frame: At 16 weeks after beginning study
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.
Anxiety symptoms
Time frame: At 4 weeks after beginning study
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.
Anxiety symptoms
Time frame: At 8 weeks after beginning study
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.
Anxiety symptoms
Time frame: At 12 weeks after beginning study
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.
Anxiety symptoms
Time frame: At 16 weeks after beginning study
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.
16 secondary outcomes
Menopause symptoms
Time frame: At 4 weeks after beginning study
Menopause symptoms
Time frame: At 8 weeks after beginning study
Menopause symptoms
Time frame: At 12 weeks after beginning study
Menopause symptoms
Time frame: At 16 weeks after beginning study
Total nightly sleep time
Time frame: At 4 weeks after beginning study
Total nightly sleep time
Time frame: At 8 weeks after beginning study
Total nightly sleep time
Time frame: At 12 weeks after beginning study
Total nightly sleep time
Time frame: At 16 weeks after beginning study
Sleep onset latency
Time frame: At 4 weeks after beginning study
Sleep onset latency
Time frame: At 8 weeks after beginning study
Sleep onset latency
Time frame: At 12 weeks after beginning study
Sleep onset latency
Time frame: At 16 weeks after beginning study
Wake after sleep onset
Time frame: At 4 weeks after beginning study
Wake after sleep onset
Time frame: At 8 weeks after beginning study
Wake after sleep onset
Time frame: At 12 weeks after beginning study
Wake after sleep onset
Time frame: At 16 weeks after beginning study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison Shea, MD principal investigator
St. Joseph's Healthcare, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Duavive 0.45Mg-20Mg Tablet in people with Menopause and Depression, Anxiety, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Shea, MD (905-521-2100 ext. 33973, ashea@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: At 4 weeks weeks after beginning study). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.