Qsiva Use Among Pregnant Women and Prescribed Contraceptive Use Among Qsiva Users of Childbearing Potential: A Postmarketing Cohort Database Study in Denmark, Finland, Norway, and Sweden

Study identification

• EU PAS number:
  EUPAS1000000886
• Study ID:
  1000000886
• Official title and acronym:
  Qsiva Use Among Pregnant Women and Prescribed Contraceptive Use Among Qsiva Users of Childbearing Potential: A Postmarketing Cohort Database Study in Denmark, Finland, Norway, and Sweden
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  Topiramate, a constituent of the fixed-dose combination drug Qsiva® (Vivus, B.V.), which is indicated for the management of obesity, has been shown in observational studies to be associated with an increased risk of oral clefts in infants exposed to the drug during the first trimester of pregnancy. Based on these identified risks, the summary of product characteristics (SmPC) includes contraindications for pregnant women and for women of childbearing potential who are not using effective methods of contraception. The SmPC also includes warnings and precautions for women of childbearing potential to use effective contraception while on treatment. This study will be conducted using national data sources from Denmark, Finland, Norway, and Sweden to evaluate whether use of Qsiva is consistent with the contraindications and warnings and precautions in the SmPC related to teratogenic risk.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned:15/09/2023

Actual:15/09/2023

Study start date

Planned:01/12/2028

Data analysis start date

Planned:01/03/2029

Date of interim report, if expected

Planned:31/12/2029

Date of final study report

Planned:30/09/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The study is funded by VIVUS LLC.

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)

Other study registration identification numbers and links

Protocol identification number: OB-906