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NCT Number: NCT03126773

A Prospective Multicenter 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.

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Key information

Conditions

Menopause

Age range

50 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Multiple Locations, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY86-4891

Drug

Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.

Primary outcomes

  1. 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".

Secondary outcomes

  1. Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment

    Time frame: Up to 4 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".

  2. Changes in menopause symptoms

    Time frame: Up to 14 months

    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.

  3. Changes in the quality of life

    Time frame: Up to 14 months

    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.

  4. Approaches to menopausal hormonal therapy prescription

    Time frame: Up to 24 months

    Approaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.

  5. Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy

    Time frame: Up to 24 months

    Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy will be considered discrete variable and reported using denoted descriptive statistics.

  6. Patients' compliance

    Time frame: Up to 24 months

    Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics.

  7. Number of early discontinuation during the first year of therapy

    Time frame: Up to 12 months

    Early discontinuation during the first year of therapy of Angeliq Micro will be considered binary.

  8. Timing of discontinuation of Angeliq® Micro

    Time frame: Up to 24 months

    Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event

  9. Reasons of discontinuation of Angeliq Micro

    Time frame: Up to 24 months

    Reasons of discontinuation of Angeliq Micro will be considered multinomial type.

  10. Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire

    Time frame: Up to 24 months

    Tolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaire

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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