A prospective, single arm, non-interventional study to evaluate the extent to which handling errors (HE) lead to Lack of Efficacy (LOE) in patients treated with ELIGARD® in France

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42056
• EU PAS number:
  EUPAS22475
• Study ID:
  42056
• Official title and acronym:
  A prospective, single arm, non-interventional study to evaluate the extent to which handling errors (HE) lead to Lack of Efficacy (LOE) in patients treated with ELIGARD® in France
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This was a non-interventional, prospective study set in routine clinical practice in France. The Drug Safety Officer (DSO) in France was to receive safety information, from a spontaneous report sent from site, regarding the occurrence of a handling error associated with the administration of ELIGARD™, and a local Pharmacovigilance (PV) case was to be created for processing in the safety database according to Astellas internal procedures.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 11/10/2017

Actual: 11/10/2017

Study start date

Planned: 30/11/2018

Actual: 19/02/2019

Data analysis start date

Planned: 15/11/2020

Date of final study report

Planned: 31/05/2021

Actual: 27/05/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas

Study protocol

Initial protocol

7015-ma-3127-fr-clrp-02-disc01-en-final-02_redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable