Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice

Study identification

• EU PAS number:
  EUPAS25373
• Study ID:
  25374
• Official title and acronym:
  Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A cohort study performed to compare the incidence of anxiety, panic attacks, sleep problems or restlessness between groups of women who were new users of levonorgestrel-releasing and non-hormonal intrauterine devices.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 27/03/2017

Actual: 27/03/2017

Study start date

Planned: 01/01/2000

Actual: 01/01/2000

Date of final study report

Planned: 21/05/2018

Actual: 21/05/2018

Sources of funding

Other

More details on funding

European Commission

Regulatory

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