Contraception Clinical Trial
Official title:
Nexplanon Observational Risk Assessment Study (NORA)
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.
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.
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