Drug Utilisation Study of conjugated oestrogens/bazedoxifene (CE/BZA) in the European Union (EU)

Study identification

• EU PAS number:
  EUPAS11604
• Study ID:
  35301
• Official title and acronym:
  Drug Utilisation Study of conjugated oestrogens/bazedoxifene (CE/BZA) in the European Union (EU)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Finland

  France

  Germany

  Italy

  Netherlands

  Spain

  Sweden

  United Kingdom
• Study description:
  Describe baseline characteristics and utilisation patterns of EU patients initiating Duavive or oestrogen + progestin (E+P) combination hormone replacement therapy (HRT), in all EU countries where CE/BZA is commercially available in 2016-2017.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 24/04/2015

Actual: 24/04/2015

Study start date

Planned: 22/10/2017

Actual: 22/10/2017

Data analysis start date

Planned: 30/09/2017

Date of interim report, if expected

Planned: 31/03/2018

Date of final study report

Planned: 31/03/2020

Actual: 31/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)