Status: Finalised First registered on: 20/03/2012
Last updated on: 03/09/2013
1. Study identification
EU PAS Register NumberEUPAS2474
Official titleIsotretinoin and the effectiveness of the pregnancy prevention programmes in Europe
Study title acronym
Study typeObservational study
Brief description of the studyIsotretinoin is effective in treating severe nodular acne vulgaris that is unresponsive to other therapies. It is, however, highly teratogenic when used during the first trimester of pregnancy and as a result, pregnancy prevention programs (PPPs) are in place committing female isotretinoin users to use ≥2 means of contraception. Research indicates that often, female isotretinoin users are unaware of these measures or do not adhere to them and the question arises as to why this should be the case. To ensure efficacy of PPPs, we need to determine what makes PPPs fail and what can be done to improve adherence. This study aims to use a combination of quantitative and qualitative research to provide an overview of isotretinoin use in women of childbearing age, to evaluate the effectiveness of the PPP and to develop and provide recommendations for improving the effectiveness of PPPs in Europe. The first 2 components of the study will use data from electronic healthcare databases in three European countries to determine the prevalence of oral isotretinoin use in females of childbearing age, to characterise its use in terms of demographic and clinical characteristics and to estimate factors predictive of PPP failure and the occurrence of pregnancies in women of childbearing age using isotretinoin. The qualitative component of the study will involve conducting interviews with women who have experienced a ‘breakthrough pregnancy’ whilst taking isotretinoin. In addition to the interviews a consultation exercise with a committee constituting representatives from across Europe of stakeholders from dermatology, hospital and community pharmacy, general practice, fertility specialists, teratology information services as well as female user representatives of childbearing potential will be carried out. All the information collected by the different components of this study will then be used to create a PPP failure model.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)?
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 belongsUniversity of Bath
Department/Research groupPharmacy & Pharmacology
Organisation/affiliationUniversity of Bath
Website/Homepagewww.bath.ac.uk
Details of (Primary) lead investigator
Title Professor
Last name de Vries
First name Corinne
Is this study being carried out with the collaboration of a research network?
Yes
EUROmediCAT
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

University of Bath
Emilia Romagna, Italy
SAIL, Wales, UK
Tuscany database, Italy
Norwegian National Birth Cohort, Norway
Countries in which this study is being conducted
International study

Italy
Norway
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/12/201116/12/2011
Start date of data collection01/01/200401/01/2004
Start date of data analysis03/09/201203/09/2012
Date of interim report, if expected
Date of final study report01/02/201311/07/2013
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 Professor
Last name de Vries
First name Corinne
Address line 1Dept. of Pharmacy & Pharmacology
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom
Phone number (incl. country code)44-1225-384228 
Alternative phone number 
Fax number (incl. country code)44-1225-386114 
Email address c.de-vries@bath.ac.uk
Public Enquiries
Title Professor 
Last name de Vries 
First name Corinne 
Address line 1Dept. of Pharmacy & Pharmacology 
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom 
Phone number (incl. country code)44-1225-384228 
Alternative phone number 
Fax number (incl. country code)44-1225-386114 
Email address c.de-vries@bath.ac.uk 
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