Post-marketing observational study to prospectively evaluate the prevalence of cognitive changes in patients suffering of PCa before starting and after six monthsof treatment with LHRH analogues (ANAMEM study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30171
• EU PAS number:
  EUPAS7870
• Study ID:
  30171
• Official title and acronym:
  Post-marketing observational study to prospectively evaluate the prevalence of cognitive changes in patients suffering of PCa before starting and after six monthsof treatment with LHRH analogues (ANAMEM study)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  ANAMEM was a post-marketing, observational, prospective, multicentre, open-label study for evaluating which proportion of patients with prostate cancer (PCa) were suffering from cognitive changes before and after six months of treatment with Luteinizing-hormone-releasing hormone (LHRH) analogues.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 22 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 23/11/2010

Actual: 23/11/2010

Study start date

Planned: 12/12/2010

Actual: 12/12/2010

Date of final study report

Planned: 10/06/2014

Actual: 10/06/2014

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