Status: Ongoing First registered on: 02/02/2015
Last updated on: 14/02/2020
1. Study identification
EU PAS Register NumberEUPAS8498
Official titlePharmacoepidemiological study (Drug Utilization Study) of JAYDESS use in routine clinical practice in Sweden
Study title acronymJaydess DUS
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCentre for Pharmacoepidemiology (CPE)
Department/Research groupDepartment of medicine/Clinical epidemiology unit
Organisation/affiliationKarolinska Institutet
Website/Homepagehttp://ki.se/meds/centrum-for-lakemedelsepidemiologi
Details of (Primary) lead investigator
Title Dr
Last name Kieler
First name Helle
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/09/201315/05/2015
Start date of data collection01/01/201701/01/2017
Start date of data analysis
Date of interim report, if expected25/10/2018
Date of final study report31/01/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Kieler
First name Helle
Address line 1T2, Karolinska University Hospital
Address line 2 
Address line 3 
CityStockholm 
Postcode 
CountrySweden
Phone number (incl. country code)46851770629 
Alternative phone number 
Fax number (incl. country code) 
Email address helle.kieler@ki.se
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials Contact 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com 
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