Clinical trial NCT01473641: Nexplanon Observational Risk Assessment Study (NORA)
Official title: Nexplanon Observational Risk Assessment Study (NORA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Etonogestrel
Contraceptive implant
Safety
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-11-17
Enrollment: 7364
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women using the contraceptive implant Nexplanon

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.

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 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

Primary outcomes:
measure: Insertion-, localization- and removal-related events
timeFrame: Within 42 months after insertion
Secondary outcomes:
measure: Pregnancy
timeFrame: Within 42 months after insertion
measure: Pregnancy outcomes
timeFrame: Within 42 months after insertion
measure: Reasons for (premature) discontinuation of Nexplanon
timeFrame: Within 42 months after insertion
measure: Baseline characteristics of Nexplanon users
timeFrame: Within 42 months after insertion
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemiology and Health Research
Study officials:
affiliation: Center for Epidemiology and Health Research, Berlin, Germany
name: Klaas Heinemann, MD, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.