Status: Finalised First registered on: 19/09/2019
Last updated on: 09/11/2022
1. Study identification
EU PAS Register NumberEUPAS31095
Official titleImpact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends
Study title acronym
Study typeObservational study
Brief description of the studyOral retinoids are used to treat dermatological conditions like severe acne vulgaris (isotretinoin) psoriasis (acitretin) and chronic hand eczema (alitretinoin), some oral retinoids are also used to treat skin manifestations of T-cell lymphoma (bexarotene) and acute promyelocytic leukaemia (tretinoin). All oral retinoids are highly teratogenic and must not be used during pregnancy. The aim of this study is to investigate the use of oral retinoid containing medicinal products authorised in the EU before and after implementation of the 2018 revised measures for pregnancy prevention in clinical practice.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsUMCU
Department/Research groupJulius Center
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Dr
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes
EU PE&PV research network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

PHARMO Institute
ARS
Danish National Registries, Denmark
BIFAP, Spain
FISABIO, Valencia, Spain
Caserta, Camania, Italy
Palermo, Sicily, Italy
SNIRAM, France
Countries in which this study is being conducted
International study

Denmark
France
Italy
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/02/201925/02/2019
Start date of data collection01/01/201001/01/2010
Start date of data analysis01/08/2020
Date of interim report, if expected
Date of final study report25/12/202131/10/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Sturkenboom
First name Miriam
Address line 1Universiteitsweg 100
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Email address m.c.j.sturkenboom@umcutrecht.nl
Public Enquiries
Title Dr 
Last name Sturkenboom 
First name Miriam 
Address line 1Universiteitsweg 100 
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Email address m.c.j.sturkenboom@umcutrecht.nl 
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