The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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/Duavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.
干预措施: Duavive 0.45Mg-20Mg Tablet (Drug)
结局指标
主要结局
Depressive symptoms
时间窗: 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
时间窗: 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.
次要结局
- Total nightly sleep time(At 16 weeks after beginning study)
- Sleep onset latency(At 16 weeks after beginning study)
- Menopause symptoms(At 16 weeks after beginning study)
- Wake after sleep onset(At 16 weeks after beginning study)
研究者
Alison Shea
Menopause and Reproductive Mental Health Specialist
St. Joseph's Healthcare Hamilton