Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04478305
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2020-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Affect of Duavive on Mood & Anxiety Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group longitudinal study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'At 4 weeks weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 8 weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 12 weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 16 weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 4 weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 8 weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 12 weeks after beginning study', 'description': '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.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'At 16 weeks after beginning study', 'description': '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.'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'At 4 weeks after beginning study', 'description': '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.'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'At 8 weeks after beginning study', 'description': '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.'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'At 12 weeks after beginning study', 'description': '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.'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'At 16 weeks after beginning study', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Menopause symptoms', 'timeFrame': 'At 4 weeks after beginning study', 'description': 'Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.'}, {'measure': 'Menopause symptoms', 'timeFrame': 'At 8 weeks after beginning study', 'description': 'Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.'}, {'measure': 'Menopause symptoms', 'timeFrame': 'At 12 weeks after beginning study', 'description': 'Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.'}, {'measure': 'Menopause symptoms', 'timeFrame': 'At 16 weeks after beginning study', 'description': 'Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.'}, {'measure': 'Total nightly sleep time', 'timeFrame': 'At 4 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Total nightly sleep time', 'timeFrame': 'At 8 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Total nightly sleep time', 'timeFrame': 'At 12 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Total nightly sleep time', 'timeFrame': 'At 16 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Sleep onset latency', 'timeFrame': 'At 4 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Sleep onset latency', 'timeFrame': 'At 8 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Sleep onset latency', 'timeFrame': 'At 12 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Sleep onset latency', 'timeFrame': 'At 16 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Wake after sleep onset', 'timeFrame': 'At 4 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Wake after sleep onset', 'timeFrame': 'At 8 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Wake after sleep onset', 'timeFrame': 'At 12 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}, {'measure': 'Wake after sleep onset', 'timeFrame': 'At 16 weeks after beginning study', 'description': 'Assessed by an Actigraph 2 monitor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hormone replacement therapy'], 'conditions': ['Menopause', 'Depression, Anxiety', 'Sleep', 'Menopause Related Conditions']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females between 45-60 years of age\n* Able to communicate in English\n* 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)\n* Suffering from Depressive symptoms (10+ on CES-D-10) AND/OR anxiety symptoms (10+ on GAD-7)\n\nExclusion Criteria:\n\n* Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.\n* Abnormal uterine bleeding that has not been adequately investigated.\n* Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).\n* Active liver disease.\n* Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.\n* Known or suspected pregnancy, women who may become pregnant, and nursing mothers\n* Partial or complete loss of vision due to ophthalmic vascular disease.\n* Uncontrolled hypertension (Systolic blood pressure \\>160mm Hg and/ or diastolic blood pressure \\>95 mm Hg)\n* 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.\n* Active serious suicidal ideation with intent.\n* Symptoms of active psychosis.\n* Daily use of antidepressive medication.\n* Use of other psychoactive or centrally acting medications within 2 weeks before study screening.\n* Known hypersensitivity to either CE or BZA."}, 'identificationModule': {'nctId': 'NCT04478305', 'acronym': 'DOMA', 'briefTitle': 'Affect of Duavive on Mood & Anxiety Symptoms', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study', 'orgStudyIdInfo': {'id': '2019-7333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention group', 'description': '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.', 'interventionNames': ['Drug: Duavive 0.45Mg-20Mg Tablet']}], 'interventions': [{'name': 'Duavive 0.45Mg-20Mg Tablet', 'type': 'DRUG', 'otherNames': ['Duavive'], 'description': 'Duavee, marketed as Duavive in Canada.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8P 3B7', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Leticia Hernandez Galan, PhD', 'role': 'CONTACT', 'email': 'lgalan@stjosham.on.ca', 'phone': '2897001324'}], 'facility': "St Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Alison Shea, MD', 'role': 'CONTACT', 'email': 'ashea@stjosham.on.ca', 'phone': '905-521-2100', 'phoneExt': '33973'}, {'name': 'Leticia Hernandez Galan, PhD', 'role': 'CONTACT', 'email': 'lgalan@stjosham.on.ca', 'phone': '2897001324'}], 'overallOfficials': [{'name': 'Alison Shea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Healthcare, McMaster University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Menopause and Reproductive Mental Health Specialist', 'investigatorFullName': 'Alison Shea', 'investigatorAffiliation': "St. Joseph's Healthcare Hamilton"}}}}