Drug utilization of Intrarosa (6.5 mg prasterone pessary) in European Countries (ERC-243)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49740
• EU PAS number:
  EUPAS26886
• Study ID:
  49740
• Official title and acronym:
  Drug utilization of Intrarosa (6.5 mg prasterone pessary) in European Countries (ERC-243)
• DARWIN EU® study:
  No
• Study countries:
  France

  Spain

  Sweden
• Study description:
  The overall aim of the DUS is to describe the baseline characteristics and utilization patterns of EU post-menopausal women initiating treatment with Intrarosa.
• Study status:
  Finalised

Research institution and networks

Institutions

IMS Health

Study timelines

Date when funding contract was signed

Actual: 20/02/2018

Study start date

Planned: 01/04/2021

Actual: 31/03/2020

Date of interim report, if expected

Actual: 29/03/2022

Date of final study report

Planned: 31/12/2022

Actual: 25/04/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Endoceutics S.A.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)