Affect of Duavive on Mood & Anxiety Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Duavive 0.45Mg-20Mg Tablet.
- Who it may be relevant to
- Registry conditions: Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions. Basic parameters: 45 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
Overview
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.
Interventions
- Drug Duavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.
Primary outcome measures
- Depressive symptoms [Time frame: At 4 weeks weeks after beginning study]
- Depressive symptoms [Time frame: At 8 weeks after beginning study]
- Depressive symptoms [Time frame: At 12 weeks after beginning study]
- Depressive symptoms [Time frame: At 16 weeks after beginning study]
- Depressive symptoms [Time frame: At 4 weeks after beginning study]
- Depressive symptoms [Time frame: At 8 weeks after beginning study]
- Depressive symptoms [Time frame: At 12 weeks after beginning study]
- Depressive symptoms [Time frame: At 16 weeks after beginning study]
- Anxiety symptoms [Time frame: At 4 weeks after beginning study]
- Anxiety symptoms [Time frame: At 8 weeks after beginning study]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- St Joseph's Healthcare — Hamilton
Identifiers
NCT: NCT04478305 · 2019-7333