Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5mg) and 17ß-estradiol (1.5mg) (PRO-E2)

First published 25/01/2012

Last updated 02/07/2024

EU PAS number:

EUPAS2196

Study

Finalised

Documents

Study protocol

Initial protocol

PRO-E2_Amendment 1 v 4_redacted

English (4.82 MB - PDF)View document

Study results

PRO_E2 Final Report_Redacted

English (6.89 MB - PDF)View document

Study report

Other information

ENCePP Seal

This study has been awarded the ENCePP seal

ENCePP Seal documents

Conflicts of interest of investigators

DoI_J Dinger_SDPP-2196 24Jul12

English (641.88 KB - PDF)View document

Composition of steering group and observers

PRO_E2_SMAC Membership for ENCEPP_Updated

English (6.48 KB - PDF)View document

SMAC Membership for ENCEPP registration

English (4.27 KB - PDF)View document

Signed code of conduct

CoC Declaration SDPP_2196

English (28.35 KB - PDF)View document

Signed code of conduct checklist

CoC Checklist SDPP_2196

English (187.42 KB - PDF)View document

Signed checklist for study protocols

Protocol Checklist SDPP_2196

English (161.92 KB - PDF)View document

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