Status: Ongoing
First registered on:
30/07/2012
Last updated on:
30/11/2014
1. Study identification
EU PAS Register NumberEUPAS2860
Official titleEmergency contraception. A safety and drug utilitation study in Spain
Study title acronym
Study typeObservational study
Brief description of the studyEmergency contraception has been a recent matter of debate in Spain. A fair and scientific-based approch is needed. To further learn upon the day after pill utilitation and safety, a combined cross-sectional (utilitation) and follow-up (safety) study is carried out in a network community pharmacies
Was this study requested by a regulator?No
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 belongsCESME
Department/Research groupCentro de Estudios sobre la Seguridad de los Medicamentos
Organisation/affiliationUniversidad de Valladolid
Details of (Primary) lead investigator
Title Professor
Last name Carvajal
First name Alfonso
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
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/01/201110/01/2011
Start date of data collection01/03/201107/03/2011
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2013
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
OtherCESME100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34983254924
Public Enquiries
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34983254924
6. Study drug(s) information
Substance class (ATC Code)G03AD (Emergency contraceptives)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Sex
Female
9. Number of subjects
Estimated total number of subjects400
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Risk assessment
Drug utilisation study
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To learn the emergency contraceptives- induced adverse reactions in a real setting
Are there primary outcomes?Yes
Whatever adverse reaction
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Between 30 and 50 days
15. Data analysis plan
Please provide a brief summary of the analysis method
Description; Risk estimation. Results of the follow-up study will be compared to those collected through spontaneus reporting.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
