DARWIN EU® - Treatment patterns in postmenopausal women in European countries: A real-world observational study

10/11/2025
11/03/2026
EU PAS number:
EUPAS1000000821
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000821

Study ID

1000000821

Official title and acronym

DARWIN EU® - Treatment patterns in postmenopausal women in European countries: A real-world observational study

DARWIN EU® study

Yes

Study countries

Denmark
Germany
Spain
United Kingdom

Study description

Vasomotor symptoms (VMS), including hot flashes and night sweats, affect up to 80% of menopausal
women and significantly impair quality of life. Hormone replacement therapy (HRT) remains the primary
treatment for VMS, with various formulations and regimens available depending on clinical factors. Despite
its widespread use, there are risks associated with HRT, which vary by age, timing, and treatment type.
However, contemporary data on HRT utilisation patterns in Europe are limited, highlighting the need for
real-world evidence to inform regulatory decisions.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Dina Vojinovic

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable