Affect of Duavive on Mood & Anxiety Symptoms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorSt. Joseph's Healthcare Hamilton
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Duavive 0.45Mg-20Mg Tablet
DrugDuavee, marketed as Duavive in Canada.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intervention groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At 4 weeks weeks after beginning study2
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.
Time frame
At 8 weeks after beginning study3
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.
Time frame
At 12 weeks after beginning study4
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.
Time frame
At 16 weeks after beginning studySecondary outcomes
1
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Time frame
At 4 weeks after beginning study2
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Time frame
At 8 weeks after beginning study3
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Time frame
At 12 weeks after beginning study4
Menopause symptoms
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.
Time frame
At 16 weeks after beginning studySponsors and contacts
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Source ClinicalTrials.gov