Trial Condition(s):

Menopause

A Prospective Multicenter study on patients’satisfaction with Angeliq® Micro in real clinical practice conducted in Russia

Bayer Identifier:

19022

ClinicalTrials.gov Identifier:

NCT03126773

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
1570
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Russia

Status
Recruiting
 

Trial Design