Diphereline Post Marketing Surveillance Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36792
• EU PAS number:
  EUPAS36791
• Study ID:
  36792
• Official title and acronym:
  Diphereline Post Marketing Surveillance Study
• DARWIN EU® study:
  No
• Study countries:
  Korea, Democratic People's Republic of
• Study description:
  To assess the efficacy and safety of Diphereline in treating Endometriosis and Fibromyoma.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 12 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 20/05/2005

Actual: 20/05/2005

Study start date

Planned: 31/05/2005

Actual: 20/05/2005

Data analysis start date

Planned: 31/03/2006

Actual: 30/12/2005

Date of final study report

Planned: 31/03/2006

Actual: 15/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable