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

Documents

Study protocol

Initial protocol

PRO-E2_Amendment 1 v 4_redacted

Study results

Study results

PRO_E2 Final Report_Redacted

Study report

Other information

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

DoI_J Dinger_SDPP-2196 24Jul12

Composition of steering group and observers

PRO_E2_SMAC Membership for ENCEPP_Updated

SMAC Membership for ENCEPP registration

Signed code of conduct

CoC Declaration SDPP_2196

Signed code of conduct checklist

CoC Checklist SDPP_2196

Signed checklist for study protocols

Protocol Checklist SDPP_2196