Nexplanon Observational Risk Assessment Study (NORA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nexplanon Observational Risk Assessment Study (NORA)

Conditions
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Contraception

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New users of Nexplanon<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etonogestrel, Contraceptive implant, Safety