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

Bayer1,570 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

1,570

Conditions

Menopause

Interventions

BAY86-4891DRUG

Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Many locations

Multiple Locations, Russia

Outcomes

Primary Outcomes

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".

Time frame: Up to 14 months

Secondary Outcomes

Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment

Time frame: 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.

Time frame: Up to 14 months

Changes in the quality of life

Time frame: 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.

Time frame: Up to 24 months

Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy

Data from ClinicalTrials.gov

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