A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

Study Overview
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Brief Summary
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To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.

Detailed Description
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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).

Official Title
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A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

Conditions
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Menopause

Intervention / Treatment
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* Drug: BAY86-4891


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY86-4891<br>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. | Drug: BAY86-4891<br>* Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment | 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. | Up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment | 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. | Up to 4 months | 
| Changes in menopause symptoms | Menopause Rating Scale (MRS) questionnaire, will be derived from MRS questionnaire at baseline and at subsequent visits (as difference V2-V1 and V3-V1) and reported using denoted descriptive statistics. | Up to 14 months | 
| Changes in the quality of life | Menopause Rating Scale (MRS) questionnaire, will be derived from MRS questionnaire at baseline and at subsequent visits (as difference V2-V1 and V3-V1) and reported using denoted descriptive statistics. | Up to 14 months | 
| Approaches to menopausal hormonal therapy prescription | Approaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics. | Up to 24 months | 
| Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy | Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy will be considered discrete variable and reported using denoted descriptive statistics. | Up to 24 months | 
| Patients' compliance | Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics. | Up to 24 months | 
| Number of early discontinuation during the first year of therapy | Early discontinuation during the first year of therapy of Angeliq Micro will be considered binary. | Up to 12 months | 
| Timing of discontinuation of Angeliq® Micro | Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event | Up to 24 months | 
| Reasons of discontinuation of Angeliq Micro | Reasons of discontinuation of Angeliq Micro will be considered multinomial type. | Up to 24 months | 
| Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire | Tolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaire | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-interventional, cohort, Angeliq Micro, menopause, Russia