Status: Planned First registered on: 05/12/2018
Last updated on: 30/07/2020
1. Study identification
EU PAS Register NumberEUPAS26886
Official titleDrug utilization of Intrarosa (6.5 mg prasterone pessary) in European Countries
Study title acronymERC-243
Study typeObservational study
Brief description of the studyThe overall aim of the DUS is to describe the baseline characteristics and utilization patterns of EU post-menopausal women initiating treatment with Intrarosa.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Montesino
First name Marlene
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
International study

France
Spain
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/02/2018
Start date of data collection31/03/2020
Start date of data analysis
Date of interim report, if expected31/12/2020
Date of final study report31/12/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEndoceutics S.A.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Martel
First name Celine
Address line 12795 Laurier Blvd
Address line 2Suite 500 
Address line 3 
CityQuebec 
PostcodeG1V 4M7 
CountryCanada
Phone number (incl. country code)14186530033 
Alternative phone number14184544323 
Fax number (incl. country code)14186531794 
Email address celine.martel@endoceutics.com
Public Enquiries
Title Dr 
Last name Montesino 
First name Marlene 
Address line 12795 Laurier Blvd 
Address line 2Suite 500 
Address line 3 
CityQuebec 
PostcodeG1V 4M7 
CountryCanada 
Phone number (incl. country code)14186530033 
Alternative phone number14185595136 
Fax number (incl. country code)14186531794 
Email address marlene.montesino@endoceutics.com 
Top