Nexplanon Observational Risk Assessment Study (NORA) (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.

Study Overview

• Status: Completed
• Conditions: Contraception

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.

• Study Type: Observational
• Enrollment (Actual): 7364

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Center for Epidemiology and Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women using the contraceptive implant Nexplanon

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
New users of Nexplanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion-, localization- and removal-related events	Incorrect insertion (i.e. unrecognized non-insertion, partial insertion, deep insertion); palpability of the implant at insertion and removal; localization of a non-palpable implant; difficult removals; pregnancy due to unrecognized non-insertion of the implant; injury to neurovascular structures in the arm; hospitalization and/or surgical procedures for localization and/or removal.	Within 42 months after insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Pre-treatment, in-treatment, post-treatment and non-insertion pregnancies.	Within 42 months after insertion
Pregnancy outcomes	Pregnancy outcomes in pregnancies where fetal exposure to etonogestrel may have taken place.	Within 42 months after insertion
Reasons for (premature) discontinuation of Nexplanon	The reason(s) the patient had the implant removed.	Within 42 months after insertion
Baseline characteristics of Nexplanon users	Baseline characteristics (including contraceptive history, medical history, gynecological history and socio-demongraphic details).	Within 42 months after insertion

Collaborators and Investigators

• Sponsor: Center for Epidemiology and Health Research, Germany
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Klaas Heinemann, MD, MBA, PhD, Center for Epidemiology and Health Research, Berlin, Germany

Publications and helpful links

General Publications

• Reed S, Do Minh T, Lange JA, Koro C, Fox M, Heinemann K. Real world data on Nexplanon(R) procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA). Contraception. 2019 Jul;100(1):31-36. doi: 10.1016/j.contraception.2019.03.052. Epub 2019 Apr 10.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Contraceptive implant; Etonogestrel
• Other Study ID Numbers: ZEG2011_03