check_circleStudy Completed
Menopause
Bayer Identifier:
19022
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Prospective Multicenter study on patients’satisfaction with Angeliq® Micro in real clinical practice conducted in Russia
Trial purpose
To evaluate the patients’ satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.
Key Participants Requirements
Sex
FemaleAge
50 - 65 YearsTrial summary
Enrollment Goal
1570Trial Dates
May 2017 - June 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Angeliq (E2/DRSP, BAY86-4891)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many locations | Many locations, Russia |
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”.date_rangeTime Frame:Up to 14 monthsenhanced_encryptionNoSafety Issue:
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”.date_rangeTime Frame:Up to 4 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 14 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 14 monthsenhanced_encryptionNoSafety Issue:
- Approaches to menopausal hormonal therapy prescriptionApproaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Patients’ compliancePatients’ compliance will be considered continuous variable and reported using denoted descriptive statistics.date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of early discontinuation during the first year of therapyEarly discontinuation during the first year of therapy of Angeliq Micro will be considered binary.date_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Timing of discontinuation of Angeliq® MicroTiming of discontinuation of Angeliq Micro will be considered right-censored time-to-eventdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Reasons of discontinuation of Angeliq MicroReasons of discontinuation of Angeliq Micro will be considered multinomial type.date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- 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 questionnairedate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A