Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Duloxetine (F1J-MC-B059)

Study identification

• EU PAS number:
  EUPAS20253
• Study ID:
  44527
• Official title and acronym:
  Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Duloxetine (F1J-MC-B059)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  There are no published large controlled studies examining the safety of duloxetine in pregnancy. Given the limitations of spontaneous adverse reports and the small sample size of the duloxetine registry, there is currently limited information regarding the safety of duloxetine in pregnancy.To determine whether exposure to duloxetine during pregnancy is associated with an increased risk of adverse maternal and fetal outcomes, including major congenital malformations, perinatal mortality, spontaneous abortion, preterm birth, and Small for Gestational Age (SGA).
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Epidemiology, Institute of Applied Economics and Health Research (ApHER)

Denmark

Study timelines

Date when funding contract was signed

Planned:07/03/2017

Actual:07/03/2017

Study start date

Planned:30/05/2018

Actual:15/10/2018

Date of final study report

Planned:28/03/2019

Actual:27/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only