Nexplanon Observational Risk Assessment Study (NORA)
Information source: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Phase: N/A
Status: Active, not recruiting
Sponsored by: Center for Epidemiology and Health Research, Germany Official(s) and/or principal investigator(s): Klaas Heinemann, MD, MBA, PhD, Principal Investigator, Affiliation: Center for Epidemiology and Health Research, Berlin, Germany
Summary
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.
Clinical Details
Official title: Nexplanon Observational Risk Assessment Study (NORA)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Insertion-, localization- and removal-related events
Secondary outcome: Pregnancy and pregnancy outcomesReasons for (premature) discontinuation of Nexplanon Baseline characteristics of Nexplanon users
Detailed 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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Center for Epidemiology and Health Research, Berlin, Germany
Additional Information
Starting date: November 2011
Last updated: June 10, 2015
|