A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,570
- 试验地点
- 1
- 主要终点
- Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment
研究概览
简要总结
To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.
详细描述
This non-interventional study is planned with the aim of obtaining information about the results of the product use in real clinical practice by means of the evaluation of the patients' satisfaction.
The study will be multicenter, non-interventional, prospective, cohort study in patients for whom their physicians have taken a decision about Angeliq Micro treatment, irrespectively of the fact of this study inclusion.
The absence of a control group (patients who receive another menopausal hormonal therapy medication, or do not receive menopausal hormonal therapy at all) is based on high risk of bias (heterogeneity of exposure in case of comparison of low-dosed and ultralow-doses menopausal hormonal therapy regiments, or in case of comparison with a group of patients for whom the menopausal hormonal therapy is not indicated).
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 50 to 65 years with vasomotor symptoms of menopause (moderate or severe in intensity), who has been prescribed or will be prescribed the menopausal hormonal therapy with Angeliq Micro.
- •Patients, who are already receiving continuous combined menopausal hormonal therapy (except Angeliq) for 3-5 years willing to continue MHT, and who will change their therapy for Angeliq Micro.
- •Patients who never ever received menopausal hormonal therapy, if at least 3 years have passed after the last menstruation, with the STRAW+10 stage +1c and younger than 60 years at the moment of inclusion.
- •Signed informed consent form (written consent for the study participation).
排除标准
- •Unwillingness or inability to give the informed consent for the study participation.
- •Contraindications for menopausal hormonal therapy (according to the Angeliq Micro SmPC).
- •Current use or history of use during 1 month before of dietary supplements containing St John's wort, as they can affect tolerability and safety of hormonal therapy.
- •Current participation in any other clinical study
研究组 & 干预措施
BAY86-4891
The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Angeliq Micro is indicated are fit for participation in this non-interventional study.
干预措施: BAY86-4891 (Drug)
结局指标
主要结局
Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment
时间窗: Up to 14 months
Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) will be considered continuous variable and reported using denoted descriptive statistics. Apart from this, patient's satisfaction will be dichotomised and analysed / reported as "satisfied / not satisfied".
次要结局
- Approaches to menopausal hormonal therapy prescription(Up to 24 months)
- Reasons of discontinuation of Angeliq Micro(Up to 24 months)
- Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire(Up to 24 months)
- Changes in the quality of life(Up to 14 months)
- Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy(Up to 24 months)
- Timing of discontinuation of Angeliq® Micro(Up to 24 months)
- Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment(Up to 4 months)
- Patients' compliance(Up to 24 months)
- Changes in menopause symptoms(Up to 14 months)
- Number of early discontinuation during the first year of therapy(Up to 12 months)