A pregnancy exposure registry study to assess clinical follow-up and outcomes of pregnancies exposed to ulipristal acetate 30 mg

Study identification

• EU PAS number:
  EUPAS33796
• Study ID:
  49109
• Official title and acronym:
  A pregnancy exposure registry study to assess clinical follow-up and outcomes of pregnancies exposed to ulipristal acetate 30 mg
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Liechtenstein

  Malta

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Spain

  Switzerland

  United Kingdom
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:27/03/2020

Actual:19/05/2020

Study start date

Planned:22/05/2020

Actual:22/05/2020

Date of final study report

Planned:21/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aristo Pharma GmbH, Aspen Healthcare Malta Limited, BIOGARAN, ELPEN Pharmaceutical Co. Inc, Eugia Pharma (Malta) Ltd., Exeltis Pharmaceuticals Holding, S.L., Farmitalia s.r.l, HELM AG, Mylan, Hexal AG, STADA Arzneimittel AG, Zentiva Group, a.s.

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)