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Nexplanon Observational Risk Assessment Study (NORA)

Information source: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Phase: N/A

Status: Active, not recruiting

Sponsored by: Center for Epidemiology and Health Research, Germany

Official(s) and/or principal investigator(s):
Klaas Heinemann, MD, MBA, PhD, Principal Investigator, Affiliation: Center for Epidemiology and Health Research, Berlin, Germany

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.

Clinical Details

Official title: Nexplanon Observational Risk Assessment Study (NORA)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Insertion-, localization- and removal-related events

Secondary outcome:

Pregnancy and pregnancy outcomes

Reasons for (premature) discontinuation of Nexplanon

Baseline characteristics of Nexplanon users

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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Center for Epidemiology and Health Research, Berlin, Germany
Additional Information

Starting date: November 2011
Last updated: June 10, 2015

Page last updated: August 23, 2015

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