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

Completed

• Conditions: Menopause
• Interventions: Drug: BAY86-4891

• Registration Number: NCT03126773
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Study Start: 2017-05-02
• Primary Completion: 2019-11-30
• Study Completion: 2020-06-18
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1570

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY86-4891	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.

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment	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".

Secondary Outcome Measures

Name	Time	Method
Approaches to menopausal hormonal therapy prescription	Up to 24 months	Approaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.
Reasons of discontinuation of Angeliq Micro	Up to 24 months	Reasons of discontinuation of Angeliq Micro will be considered multinomial type.
Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire	Up to 24 months	Tolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaire
Changes in the quality of life	Up to 14 months	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.
Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy	Up to 24 months	Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy will be considered discrete variable and reported using denoted descriptive statistics.
Timing of discontinuation of Angeliq® Micro	Up to 24 months	Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event
Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment	Up to 4 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".
Patients' compliance	Up to 24 months	Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics.
Changes in menopause symptoms	Up to 14 months	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.
Number of early discontinuation during the first year of therapy	Up to 12 months	Early discontinuation during the first year of therapy of Angeliq Micro will be considered binary.

Trial Locations

Locations (1)

Many locations; 🇷🇺 Multiple Locations, Russian Federation