POST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 669
- 试验地点
- 19
- 主要终点
- Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit
研究概览
简要总结
To evaluate safety and efficacy of CE/BZA in real practice in Korea
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Severe post menopausal vasomotor symptoms with uterus
- •postmenopausal osteopenia
排除标准
- •Women with undiagnosed abnormal uterine bleeding
- •Women with known, suspected, or past history of breast cancer
- •Women with known or suspected estrogen-dependent neoplasia
- •Women with active deep venous thrombosis, pulmonary embolism, or history of these conditions
- •Women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions
- •Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists
- •Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients
- •Women with known hepatic impairment or disease
- •Women with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
- •Pregnant women, women who may become pregnant, and nursing mothers
- •Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
结局指标
主要结局
Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit
时间窗: Baseline, Last visit (last visit was anytime up to a maximum of Month 21)
Improvement from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved.
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6
时间窗: Baseline, Month 6
Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6
时间窗: Month 6
Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 28 days after last dose of study drug (up to 22 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. A treatment-related adverse event was any untoward medical occurrence attributed to Duavive tablet in a participant who received Duavive tablet. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Duavive tablet was assessed by the investigator.
Number of Participants Classified According to Measures Taken for Adverse Events
时间窗: Baseline up to 28 days after last dose of study drug (up to 22 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Following measures were taken for AEs in relation to Duavive tablet: no change in treatment, permanently discontinued treatment and temporarily discontinued treatment.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 28 days after last dose of study drug (up to 22 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3
时间窗: Baseline, Month 3
Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3
时间窗: Month 3
Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.
Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit
时间窗: Last visit (last visit was anytime up to a maximum of Month 21)
Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.
次要结局
未报告次要终点