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

Bayer

Status: Completed

Conditions: Menopause

Treatments: Drug: BAY86-4891

Study type: Observational

Funder types: Industry

Identifiers

NCT03126773

19022

Details and patient eligibility

About

To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.

Full 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).

Enrollment: 1,570 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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 design

1,570 participants in 1 patient group

BAY86-4891

Description:

The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Angeliq Micro is indicated are fit for participation in this non-interventional study.

Treatment:

Drug: BAY86-4891