Butoconazole use in pregnancy: population-based case-control studies on adverse pregnancy outcomes in Hungary (study protocol RGD-77425)

Documents

Study protocol

Initial protocol

Final study protocol RGD77425_20130708

Updated protocol

Study protocol RGD77425_Amendment 1_clean_FINAL

First published: 22/02/2024

Study results

Study results

Final Report_20161121_signed_Vol1

Protocol Amendment2_final_clean

Study report

Study report

15_1_8

Final Report_20161121_signed_Vol2

Final Report_20161121_signed_Vol3

Other information

Study, other information

approval-for-the-clinical-trial-GYEMSZI

butoconazole-nitrate-approval-modification

Final Report_20161121_signed_Vol2.pdf

Final Report_20161121_signed_Vol3.pdf

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 The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

Signed checklist for study protocols

ENCEPP checklist 20150717

Microsoft Word - ENCePP Checklist study RGD77425_20130708