Status: Ongoing First registered on: 15/10/2012
Last updated on: 10/02/2020
1. Study identification
EU PAS Register NumberEUPAS3057
Official titleVenlafaxine exposure in pregnancy, a multicenter ENTIS study
Study title acronym
Study typeObservational study
Brief description of the studyIntroduction Venlafaxine (Efexor®) is a serotonin and noradrenaline reuptake inhibitor (SNRI) used for the treatment of depression and anxiety disorders. The limited data on the use of venlafaxine in human pregnancy do not indicate an increased risk of congenital malformations. The main purpose of the study is to assess the rate of major malformations after first trimester exposure to venlafaxine. Methods This multicenter, prospective cohort study was performed using data from eight centers who are member of the European Network of Teratology Information Services (ENTIS). Data on pregnancy and pregnancy outcome of women who used venlafaxine in pregnancy were collected during individual risk counseling. Standardized procedures for data collection and follow-up were used by each center.
Was this study requested by a regulator?No
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 belongsNetherlands Pharmacovigilance Centre Lareb
Department/Research groupTIS
Organisation/affiliationNetherlands Pharmacovigilance Centre Lareb
Website/Homepagewww.lareb.nl
Details of (Primary) lead investigator
Title Miss
Last name te Winkel
First name Bernke
Is this study being carried out with the collaboration of a research network?
Yes

ENTIS
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?9

TIS Helsinki
Centre de Référence sur les Agents Tératogènes (CRAT), Paris, France
Florence Teratology Information Service, Careggi university hospital, Florence, Italy
CEPIG, Genetica Clinica, Azienda Ospedaliera Padov, Padova, Italy
Poison Control Centre and Teratology Information Service, Ospedali, Bergamo, Italy
Swiss Teratogen Information Service and Division of clinical Pharmacology and Toxicology, University Hospital, Lausanne, Lausanne, Switserland
BELTIS Rabin. Medical. Center Petah-Tikva Affiliated with the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
Telefono Rosso, Catholic University of Sacred Heart, Rome, Italy
Countries in which this study is being conducted
International study

Finland
France
Israel
Italy
Netherlands
Switzerland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/09/2008
Start date of data collection27/10/2008
Start date of data analysis
Date of interim report, if expected
Date of final study report28/12/2020
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 bodyMinistery of Health, The Netherlands100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Miss
Last name te Winkel
First name Bernke
Address line 1Goudsbloemvallei 7
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code)31-73-6426136 
Email address b.tewinkel@lareb.nl
Public Enquiries
Title Miss 
Last name te Winkel 
First name Bernke 
Address line 1Goudsbloemvallei 7 
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands 
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code)31-73-6426136 
Email address b.tewinkel@lareb.nl 
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