Study identification

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

Contact details

Klaas Heinemann

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Sharp and Dohme Corp
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)