[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399217":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":26,"locations":37,"responsibleParty":54,"collaborators":57,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":35,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":40,"whyStopped":35,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Intervention group","Patient will be provided with study medication. To be taken once a day for 16 weeks (112 days). Active drug brand name - Duavive\u002FDuavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.",[12],"Drug: Duavive 0.45Mg-20Mg Tablet",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Duavive 0.45Mg-20Mg Tablet","Duavee, marketed as Duavive in Canada.",[9],[20],"Duavive",[22],{"name":23,"affiliation":24,"role":25},"Alison Shea, MD","St. Joseph's Healthcare, McMaster University","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","905-521-2100","33973","ashea@stjosham.on.ca",{"name":33,"role":28,"phone":34,"phoneExt":35,"email":36},"Leticia Hernandez Galan, PhD","2897001324",null,"lgalan@stjosham.on.ca",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"St Joseph's Healthcare","RECRUITING","Hamilton","Ontario","L8P 3B7","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-79.84963,43.25011,{"lat":50,"lon":49},[53],{"name":33,"role":28,"phone":34,"phoneExt":35,"email":36},{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Alison Shea","Menopause and Reproductive Mental Health Specialist",[58,60],{"name":59,"class":6},"McMaster University",{"name":61,"class":62},"Pfizer","INDUSTRY","100399217","phase-1-affect-of-duavive-on-mood--anxiety-symptoms-100399217",false,"NCT04478305","Affect of Duavive on Mood & Anxiety Symptoms","The Effect of Conjugated Estrogens\u002F Bazedoxifene (CE\u002F BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study","DOMA","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\u002FOR anxiety symptoms (10+ on GAD-7)\n\nExclusion Criteria:\n\n* Personal history of breast\u002F ovarian\u002F endometrial cancer\u002F 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\u002F 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.","FEMALE","45 Years","60 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","This study evaluates the impact of conjugated estrogens\u002F bazedoxifene (CE\u002F BZA) on the mood (depression and anxiety) in peri- and early menopausal women.",[82,83,84,85],"Menopause","Depression, Anxiety","Sleep","Menopause Related Conditions",[87],"hormone replacement therapy","2024-11-28",{"date":90,"type":91},"2024-12-03","ACTUAL",{"date":93,"type":91},"2024-07-03",{"date":95,"type":76},"2025-12",{"name":5,"class":6},1]