Nexplanon Observational Risk Assessment Study (NORA)

Center for Epidemiology and Health Research, Germany

Status: Completed

Conditions: Contraception

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01473641

ZEG2011_03

Details and patient eligibility

About

This study characterises the frequency of specific insertion-, localization- and removal-related events and clinically significant consequences thereof among Nexplanon users in the US during routine clinical use.

Full description

Nexplanon is a subdermal contraceptive implant containing the progestogen etonogestrel. It provides contraceptive protection for three years. In addition to the progestogen, Nexplanon contains barium sulfate and a Next Generation Implanon Applicator (NGIA). Nexplanon was developed to further facilitate correct insertion of the implant by using the NGIA, and to extend the diagnostic modalities for localization of the implant by making it radiopaque and visible via X-ray imaging and X-ray Computerized Tomography (CT).

A large, descriptive, prospective, non-interventional, observational cohort study is planned to follow a cohort of new users of the contraceptive implant Nexplanon. Women will be recruited through health care professionals who have completed the Nexplanon Clinical Training Program. Baseline and follow-up information will be collected via a self-administered questionnaire. Data analysis will include characterizing the frequency of specific insertion-, localization- and removal-related events via point-estimates of the event rate as well as 95% confidence intervals. The impact of potential prognostic factors will be analyzed using multivariate regression models and/or stratified analyses.

Enrollment: 7,364 patients

Sex: Female

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women prescribed a new Nexplanon implant
• Women who are capable of understanding the major aspects of the study and can complete the self-administered questionnaire in English

Exclusion criteria

• Women who are not willing to sign the informed consent form

Trial design

7,364 participants in 1 patient group

New users of Nexplanon