Trial Condition(s):
Menopause
A Prospective Multicenter study on patients’satisfaction with Angeliq® Micro in real clinical practice conducted in Russia
Bayer Identifier:
19022
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
To evaluate the patients’ satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.
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
Trial Summary
Enrollment Goal
1570
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Russia | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A Prospective Multicenter non-interventional cohort study on patients’satisfaction with Angeliq® Micro in real clinical practice conducted in Russia
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Patient’s satisfaction with the menopausal symptoms treatment after 13 cycles of treatmentMenopause 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”.Timeframe: Up to 14 months
Secondary Outcome
- Patient’s satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatmentMenopause 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”.Timeframe: Up to 4 months
- Changes in menopause symptomsMenopause 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.Timeframe: Up to 14 months
- Changes in the quality of lifeMenopause 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.Timeframe: Up to 14 months
- Approaches to menopausal hormonal therapy prescriptionApproaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.Timeframe: Up to 24 months
- Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapyReasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy will be considered discrete variable and reported using denoted descriptive statistics.Timeframe: Up to 24 months
- Patients’ compliancePatients’ compliance will be considered continuous variable and reported using denoted descriptive statistics.Timeframe: Up to 24 months
- Number of early discontinuation during the first year of therapyEarly discontinuation during the first year of therapy of Angeliq Micro will be considered binary.Timeframe: Up to 12 months
- Timing of discontinuation of Angeliq® MicroTiming of discontinuation of Angeliq Micro will be considered right-censored time-to-eventTimeframe: Up to 24 months
- Reasons of discontinuation of Angeliq MicroReasons of discontinuation of Angeliq Micro will be considered multinomial type.Timeframe: Up to 24 months
- Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaireTolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaireTimeframe: Up to 24 months
Additional Information
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