International Active Surveillance study - Folate and Oral Contraceptive Utilization Study (INAS-FOCUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36862
• EU PAS number:
  EUPAS1597
• Study ID:
  36862
• Official title and acronym:
  International Active Surveillance study - Folate and Oral Contraceptive Utilization Study (INAS-FOCUS)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Russian Federation

  Ukraine

  United States
• Study description:
  Oral Contraceptives containing DRSP have been available since 1995. Numerous studies have supported and refuted the hypothesis that DRSP contraceptives have an increased risk of VTE compared with LNG containing OCs. The scientific debate regarding VTE risk is ongoing necessitating an additional PASS study in this field. In addition, whilst there is probably no impact of folate on VTE risk, robust clinical data is not available and therefore an investigation of the VTE risk associated with the combination of DRSP/EE is required.A 15-year follow-up phase was initially planned for INAS-FOCUS to examine the association between DRSP/EE+ and Colorectal cancer (CRC). Because of the rarity of CRC, the recruitments rates and exposure figures observed, strongly suggest that the assessment of the risk of CRC for this study will not have power to draw meaningful conclusions and a decision was made to discontinue the study after the cardiovascular results. An amended protocol and statistical analysis plan (SAP) was approved by Safety Monitoring and Advisory Council on 13th May, 2018. Details regarding Part II (colorectal cancer outcomes) have been removed from both the protocol and SAP. Colorectal cancer and other cancer outcomes will be analyzed as secondary outcomes. In addition, reference to a third cohort (DNG/EE+) was removed from the protocol as this oral contraceptive never came to market.
• Study status:
  Finalised

Research institution and networks

Institutions

Berlin Center for Epidemiology & Health Research, ZEG Berlin

Germany

Study timelines

Date when funding contract was signed

Planned: 01/04/2010

Actual: 14/05/2010

Study start date

Planned: 22/11/2010

Actual: 01/12/2010

Data analysis start date

Actual: 02/10/2019

Date of final study report

Planned: 31/03/2020

Actual: 19/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Schering Pharmaceuticals

Study protocol

Initial protocol

Protocol INAS-FOCUS

Updated protocol

Protocol INAS-FOCUS_V02-00

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)