Nexplanon Observational Risk Assessment Study (NORA)

Contraception Clinical Trial

— NORA  

Official title:

Nexplanon Observational Risk Assessment Study (NORA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473641
• Other study ID #: ZEG2011_03
• Status: Completed
• Start date: November 2011
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2019
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7364
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
Germany	Center for Epidemiology and Health Research	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Reed S, Do Minh T, Lange JA, Koro C, Fox M, Heinemann K. Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA). Contraception. 2019 Jul;100(1):31-36. doi: 10.1016/j.contraceptio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pregnancy	Pre-treatment, in-treatment, post-treatment and non-insertion pregnancies.	Within 42 months after insertion
Secondary	Pregnancy outcomes	Pregnancy outcomes in pregnancies where fetal exposure to etonogestrel may have taken place.	Within 42 months after insertion
Secondary	Reasons for (premature) discontinuation of Nexplanon	The reason(s) the patient had the implant removed.	Within 42 months after insertion
Secondary	Baseline characteristics of Nexplanon users	Baseline characteristics (including contraceptive history, medical history, gynecological history and socio-demongraphic details).	Within 42 months after insertion