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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126773
• Other study ID #: 19022
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: June 18, 2020

Study information

• Verified date: June 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1570
• Est. completion date: June 18, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• BAY86-4891
Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.

Locations

Country	Name	City	State
Russian Federation	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patients' compliance	Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics.	Up to 24 months
Secondary	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
Secondary	Timing of discontinuation of Angeliq® Micro	Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event	Up to 24 months
Secondary	Reasons of discontinuation of Angeliq Micro	Reasons of discontinuation of Angeliq Micro will be considered multinomial type.	Up to 24 months
Secondary	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

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