Overview

This trial is active, not recruiting.

Condition contraception
Sponsor Center for Epidemiology and Health Research, Germany
Collaborator Merck Sharp & Dohme Corp.
Start date November 2011
End date October 2017
Trial size 7384 participants
Trial identifier NCT01473641, ZEG2011_03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Insertion-, localization- and removal-related events
time frame: Within 42 months after insertion

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 12 years old.

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

Additional Information

Official title Nexplanon Observational Risk Assessment Study (NORA)
Principal investigator Klaas Heinemann, MD, MBA, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Center for Epidemiology and Health Research, Germany.