- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126773
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
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Multiple Locations, Russian Federation
- Many locations
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.
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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
Time Frame: Up to 14 months
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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".
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Up to 14 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment
Time Frame: Up to 4 months
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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".
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Up to 4 months
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Changes in menopause symptoms
Time Frame: Up to 14 months
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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.
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Up to 14 months
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Changes in the quality of life
Time Frame: Up to 14 months
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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.
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Up to 14 months
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Approaches to menopausal hormonal therapy prescription
Time Frame: Up to 24 months
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Approaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.
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Up to 24 months
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Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy
Time Frame: Up to 24 months
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Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy will be considered discrete variable and reported using denoted descriptive statistics.
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Up to 24 months
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Patients' compliance
Time Frame: Up to 24 months
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Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics.
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Up to 24 months
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Number of early discontinuation during the first year of therapy
Time Frame: Up to 12 months
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Early discontinuation during the first year of therapy of Angeliq Micro will be considered binary.
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Up to 12 months
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Timing of discontinuation of Angeliq® Micro
Time Frame: Up to 24 months
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Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event
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Up to 24 months
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Reasons of discontinuation of Angeliq Micro
Time Frame: Up to 24 months
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Reasons of discontinuation of Angeliq Micro will be considered multinomial type.
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Up to 24 months
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Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire
Time Frame: Up to 24 months
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Tolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaire
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Up to 24 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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