Nexplanon Observational Risk Assessment Study (NORA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31766
• EU PAS number:
  EUPAS1999
• Study ID:
  31766
• Official title and acronym:
  Nexplanon Observational Risk Assessment Study (NORA)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Nexplanon is a subdermal contraceptive implant containing the progestogen etonogestrel and providing continuous contraceptive protection for three years. In contrast to its predecessor, Implanon, Nexplanon (etonogestrel radiopaque implant) contains barium sulfate and has a new Next Generation Implanon Applicator (NGIA) application device. The barium sulfate will extend the diagnostic modalities for localization of the implant by making it radiopaque and hence visible via X-ray imaging and X-ray Computerized Tomography (CT). It is anticipated that the NGIA should further facilitate correct insertion of the implant in the subdermal layer of the skin. The NORA study is designed to collect information on insertion-, localization- and removal-related events. The study is being conducted as a post-approval regulatory commitment for the FDA and includes a single cohort of US women using Nexplanon. The objective of the study is to characterize the frequency of specific insertion-, localization- and removal-related events and clinically significant consequences thereof among Nexplanon users in the US during standard clinical practice.
• 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: 01/04/2011

Actual: 04/04/2011

Study start date

Planned: 01/12/2011

Actual: 06/12/2011

Data analysis start date

Actual: 31/10/2017

Date of final study report

Planned: 01/02/2018

Actual: 20/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp and Dohme Corp

Study protocol

Initial protocol

NORA Protocol_final

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)