Pharmacoepidemiological study (Drug Utilization Study) of JAYDESS use in routine clinical practice in Sweden (Jaydess DUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33634
• EU PAS number:
  EUPAS8498
• Study ID:
  33634
• Official title and acronym:
  Pharmacoepidemiological study (Drug Utilization Study) of JAYDESS use in routine clinical practice in Sweden (Jaydess DUS)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  The aim is to characterise new users of Jaydess and estimate duration of use and describe hormonal contraceptive methods prior to use of, and after discontinuing, Jaydess. The study will comprise a pilot study including users of Mirena and a main study including users of Jaydess. The main study will include 3 parts using different type and level of information from the national and regional registers. Validation will be carried out by comparing the information in the registers with that in the medical records for a randomly selected sample of the study population.
• Study status:
  Finalised

Research institution and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Planned: 02/09/2013

Actual: 15/05/2015

Study start date

Planned: 01/01/2017

Actual: 01/01/2017

Date of interim report, if expected

Actual: 25/10/2018

Date of final study report

Planned: 31/01/2023

Actual: 02/11/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

JaydessDUSSweden_20140112 clean

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)