ContraceptionNORANCT01473641
Nexplanon Observational Risk Assessment Study (NORA)
An observational study of Contraception, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 7,364 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women using the contraceptive implant Nexplanon
Who may be able to join
- 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
Who cannot join
- Women who are not willing to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Contraception
- Keywords
- Etonogestrel, Contraceptive implant, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New users of Nexplanon | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 42 months after insertion
Secondary outcomes (4)
Pregnancy
Pre-treatment, in-treatment, post-treatment and non-insertion pregnancies.
Measured: Within 42 months after insertion
Pregnancy outcomes
Pregnancy outcomes in pregnancies where fetal exposure to etonogestrel may have taken place.
Measured: Within 42 months after insertion
Reasons for (premature) discontinuation of Nexplanon
The reason(s) the patient had the implant removed.
Measured: Within 42 months after insertion
Baseline characteristics of Nexplanon users
Baseline characteristics (including contraceptive history, medical history, gynecological history and socio-demongraphic details).
Measured: Within 42 months after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
- Investigators
- Klaas Heinemann, MD, MBA, PhD, Principal investigator, Center for Epidemiology and Health Research, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473641
- Sponsor's protocol ID
- ZEG2011_03
- Acronym
- NORA
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2011
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30980829
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nexplanon Observational Risk Assessment Study (NORA)
- ClinicalTrials.gov ID
- NCT01473641
- Acronym / sponsor ID
- NORA / ZEG2011_03
- Conditions
- Contraception
- Keywords
- Etonogestrel, Contraceptive implant, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,364 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2011
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New users of Nexplanon | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women using the contraceptive implant Nexplanon
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Women who are not willing to sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Pregnancy
Time frame: Within 42 months after insertion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Results publication: PubMed 30980829Reed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaas Heinemann, MD, MBA, PhD principal investigator
Center for Epidemiology and Health Research, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion-, localization- and removal-related events (time frame: Within 42 months after insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.