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Completed

NCT Number: NCT01473641

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.

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Key information

Conditions

Contraception

Age range

12 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Center for Epidemiology and Health Research

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Insertion-, localization- and removal-related events

    Time frame: 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 outcomes

  1. Pregnancy

    Time frame: Within 42 months after insertion

    Pre-treatment, in-treatment, post-treatment and non-insertion pregnancies.

  2. Pregnancy outcomes

    Time frame: Within 42 months after insertion

    Pregnancy outcomes in pregnancies where fetal exposure to etonogestrel may have taken place.

  3. Reasons for (premature) discontinuation of Nexplanon

    Time frame: Within 42 months after insertion

    The reason(s) the patient had the implant removed.

  4. Baseline characteristics of Nexplanon users

    Time frame: Within 42 months after insertion

    Baseline characteristics (including contraceptive history, medical history, gynecological history and socio-demongraphic details).

Sponsors and collaborators

Lead sponsor

Center for Epidemiology and Health Research, Germany

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: NORA

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2011
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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