Nexplanon Observational Risk Assessment Study (NORA)

Completed

• Conditions: Contraception

• Registration Number: NCT01473641
• Lead Sponsor: Center for Epidemiology and Health Research, Germany

Brief 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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7364

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insertion-, localization- and removal-related events	Within 42 months after insertion	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Epidemiology and Health Research; 🇩🇪 Berlin, Germany