Nexplanon Observational Risk Assessment Study (NORA)
NORA
1 other identifier
observational
7,364
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedNovember 7, 2019
November 1, 2019
6 years
November 15, 2011
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Pregnancy
Within 42 months after insertion
Pregnancy outcomes
Within 42 months after insertion
Reasons for (premature) discontinuation of Nexplanon
Within 42 months after insertion
Baseline characteristics of Nexplanon users
Within 42 months after insertion
Study Arms (1)
New users of Nexplanon
Eligibility Criteria
Women using the contraceptive implant Nexplanon
You may qualify if:
- 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
You may not qualify if:
- Women who are not willing to sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Epidemiology and Health Research
Berlin, Germany
Related Publications (1)
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.
PMID: 30980829RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Klaas Heinemann, MD, MBA, PhD
Center for Epidemiology and Health Research, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 15, 2011
First Posted
November 17, 2011
Study Start
November 1, 2011
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
November 7, 2019
Record last verified: 2019-11