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Nexplanon Observational Risk Assessment Study (NORA) (NORA)

This study is ongoing, but not recruiting participants.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany Identifier:
First received: November 15, 2011
Last updated: May 17, 2017
Last verified: May 2017
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexplanon Observational Risk Assessment Study (NORA)

Resource links provided by NLM:

Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pregnancy and pregnancy outcomes [ Time Frame: Within 42 months after insertion ]
  • Reasons for (premature) discontinuation of Nexplanon [ Time Frame: Within 42 months after insertion ]
  • Baseline characteristics of Nexplanon users [ Time Frame: Within 42 months after insertion ]

Enrollment: 7384
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
New users of Nexplanon

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.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women using the contraceptive implant Nexplanon

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01473641

Center for Epidemiology and Health Research
Berlin, Germany
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Merck Sharp & Dohme Corp.
Principal Investigator: Klaas Heinemann, MD, MBA, PhD Center for Epidemiology and Health Research, Berlin, Germany
  More Information

Responsible Party: Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany Identifier: NCT01473641     History of Changes
Other Study ID Numbers: ZEG2011_03
Study First Received: November 15, 2011
Last Updated: May 17, 2017

Keywords provided by Center for Epidemiology and Health Research, Germany:
Contraceptive implant

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on May 24, 2017