Observational Studies to Assess Maternal and Fetal Outcomes Following Exposure to Duloxetine (F1J-MC-B057)

Study identification

• EU PAS number:
  EUPAS15946
• Study ID:
  32283
• Official title and acronym:
  Observational Studies to Assess Maternal and Fetal Outcomes Following Exposure to Duloxetine (F1J-MC-B057)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study was designed to assess the risk of major congenital malformations, preterm delivery, small for gestational age, and preeclampsia associated with duloxetine use in pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Brigham and Women's Hospital

Study timelines

Date when funding contract was signed

Planned: 01/11/2016

Actual: 14/04/2016

Study start date

Planned: 01/11/2016

Actual: 01/11/2016

Data analysis start date

Planned: 01/12/2016

Date of final study report

Planned: 31/10/2018

Actual: 30/10/2019

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)?:
  EU RMP category 3 (required)