Clinical trial NCT03126773: A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
Official title: A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: non-interventional
cohort
Angeliq Micro
menopause
Russia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 1570
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged 50 to 65 years with vasomotor symptoms of menopause

Brief summary: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment
timeFrame: Up to 14 months
Secondary outcomes:
measure: Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment
timeFrame: Up to 4 months
measure: Changes in menopause symptoms
timeFrame: Up to 14 months
measure: Changes in the quality of life
timeFrame: Up to 14 months
measure: Approaches to menopausal hormonal therapy prescription
timeFrame: Up to 24 months
measure: Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy
timeFrame: Up to 24 months
measure: Patients' compliance
timeFrame: Up to 24 months
measure: Number of early discontinuation during the first year of therapy
timeFrame: Up to 12 months
measure: Timing of discontinuation of Angeliq® Micro
timeFrame: Up to 24 months
measure: Reasons of discontinuation of Angeliq Micro
timeFrame: Up to 24 months
measure: Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Russian Federation
facility: Many locations
Study officials:
References: