check_circleStudy Completed

Menopause

Bayer Identifier:

19022

ClinicalTrials.gov Identifier:

NCT03126773

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

Female

Age

50 - 65 Years
  • - 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).
  • - 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
May 2017 - June 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Russia

Primary Outcome

  • 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”.
    date_rangeTime Frame:
    Up to 14 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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”.
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 14 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 14 months
    enhanced_encryption
    Safety Issue:
    No
  • Approaches to menopausal hormonal therapy prescription
    Approaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Patients’ compliance
    Patients’ compliance will be considered continuous variable and reported using denoted descriptive statistics.
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Timing of discontinuation of Angeliq® Micro
    Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Reasons of discontinuation of Angeliq Micro
    Reasons of discontinuation of Angeliq Micro will be considered multinomial type.
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here to find results for studies related to Bayer products