MenopauseNCT03126773
A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
An observational study of Menopause, run by Bayer at 1 site in Russia.
Trial summary
To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- BAY86-4891
- Type of treatment
- Pill or oral medicine
- How many people
- 1,570 participants
- Where
- 1 siteRussia
- Study dates
- 2 May 2017to 18 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 50 to 65 years with vasomotor symptoms of menopause
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Menopause
- Being tested
- BAY86-4891
- Keywords
- non-interventional, cohort, Angeliq Micro, menopause, Russia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-4891Drug
Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BAY86-4891 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Up to 14 months
Secondary outcomes (10)
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Patients' compliance
Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics.
Measured: 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.
Measured: Up to 12 months
Timing of discontinuation of Angeliq® Micro
Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event
Measured: Up to 24 months
Reasons of discontinuation of Angeliq Micro
Reasons of discontinuation of Angeliq Micro will be considered multinomial type.
Measured: 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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start2 May 2017
- Primary completion30 Nov 2019
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126773
- Sponsor's protocol ID
- 19022
- Status last verified
- Jun 2021
- First submitted
- 20 Apr 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
- ClinicalTrials.gov ID
- NCT03126773
- Acronym / sponsor ID
- 19022
- Conditions
- Menopause
- Keywords
- non-interventional, cohort, Angeliq Micro, menopause, Russia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,570 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY86-4891 | – | Drug: BAY86-4891The 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 50 to 65 years with vasomotor symptoms of menopause
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY86-4891Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day. | Drug | BAY86-4891 |
Primary outcome
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".
10 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
Time frame: Up to 14 months
Changes in the quality of life
Time frame: Up to 14 months
Approaches to menopausal hormonal therapy prescription
Time frame: Up to 24 months
Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy
Time frame: Up to 24 months
Patients' compliance
Time frame: Up to 24 months
Number of early discontinuation during the first year of therapy
Time frame: Up to 12 months
Timing of discontinuation of Angeliq® Micro
Time frame: Up to 24 months
Reasons of discontinuation of Angeliq Micro
Time frame: Up to 24 months
Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Bayer at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment (time frame: Up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.