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

June 15, 2021 updated by: Bayer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment
Time Frame: 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".
Up to 14 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment
Time Frame: 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".
Up to 4 months
Changes in menopause symptoms
Time Frame: 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.
Up to 14 months
Changes in the quality of life
Time Frame: 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.
Up to 14 months
Approaches to menopausal hormonal therapy prescription
Time Frame: Up to 24 months
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
Time Frame: 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.
Up to 24 months
Patients' compliance
Time Frame: Up to 24 months
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
Time Frame: Up to 12 months
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
Time Frame: Up to 24 months
Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event
Up to 24 months
Reasons of discontinuation of Angeliq Micro
Time Frame: Up to 24 months
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
Time Frame: Up to 24 months
Tolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaire
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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