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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16983
• EU PAS number:
  EUPAS4282
• Study ID:
  16983
• Official title and acronym:
  Butoconazole use in pregnancy: population-based case-control studies on adverse pregnancy outcomes in Hungary (study protocol RGD-77425)
• DARWIN EU® study:
  No
• Study countries:
  Hungary
• Study status:
  Finalised

Research institutions and networks

Institutions

Semmelweis University

Hungary

Study timelines

Date when funding contract was signed

Planned: 10/07/2013

Actual: 05/07/2013

Study start date

Planned: 10/09/2013

Actual: 20/01/2014

Data analysis start date

Planned: 01/11/2013

Actual: 10/02/2014

Date of final study report

Planned: 30/06/2016

Actual: 21/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gedeon Richter Plc.

Study protocol

Initial protocol

Final study protocol RGD77425_20130708

Updated protocol

Study protocol RGD77425_Amendment 1_clean_FINAL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable