EURopean Active Surveillance study - Comparing Regimens of Administration in combined hormonal contraception (EURAS - CORA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29837
• EU PAS number:
  EUPAS9818
• Study ID:
  29837
• Official title and acronym:
  EURopean Active Surveillance study - Comparing Regimens of Administration in combined hormonal contraception (EURAS - CORA)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Hungary

  Italy

  Poland

  Spain
• Study description:
  Lisvy (FC Patch Low) is a transdermal contraceptive patch releasing 60mcg gestodene/24 hours and 13 mcg ethinyl estradiol/24 hours. FC Patch Low is applied once a week for three consecutive weeks followed by a break of one week (21/7). One patch contains 2.1mg gestodene and 0.55mg ethinyl estradiol. The most relevant adverse clinical outcomes that have been linked to the use of COCs is venous thromboembolism (VTE). EURAS-CORA is a large, prospective, controlled, long-term active surveillance study to investigate the safety of FC Patch Low with regard to venous thromboembolism, arterial thromboembolism, cancer, long and short term fertility and pregnancy outcomes and application site reactions. The study follows the EURAS design methodology with some modifications due to country and product-specific characteristics. EURAS-CORA was suspended on 17th October 2016. FC Patch Low was withdrawn from the market. Under certain conditions the stability tests showed out of specification results. Data from in vitro dissolution tests showed altered dissolution profile for the gestodene component. Furthermore, visually observable quality defect of crystallization due to the progesterone component (gestodene) had been detected. The clinical relevance of the quality issue was not proven. Based on the company’s safety database, no increase in the frequency of reported adverse events or in the number of unwanted pregnancies were observed in association with the quality issue of the patch. The Pearl Index calculated based on this post-marketing data and taking into account the possible under-reporting (Pearl Index: 0.50) was considerably lower than the Pearl Index based on the data from clinical trials (Pearl Index: 1.19). The market authorization of the product was withdrawn in all European countries between May 2018 and January 2019. The EURAS-CORA study closed on 22nd May 2019.
• Study status:
  Finalised

Research institutions and networks

Institutions

Berlin Center for Epidemiology & Health Research, ZEG Berlin

Germany

Study timelines

Date when funding contract was signed

Planned: 01/04/2015

Actual: 07/09/2015

Study start date

Planned: 01/11/2015

Actual: 27/11/2015

Data analysis start date

Planned: 01/07/2016

Date of final study report

Planned: 30/04/2022

Actual: 18/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gedeon Richter

Study protocol

Initial protocol

EURAS-CORA_Study Protocol_ENCePP Submission

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)