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

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

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

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: BAY86-4891

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).

• Study Type: Observational
• Enrollment (Actual): 1570

Contacts and Locations

Study Locations

• Russian Federation
  • Multiple Locations, Russian Federation
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patients aged 50 to 65 years with vasomotor symptoms of menopause

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: BAY86-4891; Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: menopause; Russia; cohort; non-interventional; Angeliq Micro
• Other Study ID Numbers: 19022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No