Nexplanon Observational Risk Assessment Study (NORA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Center for Epidemiology and Health Research, Germany
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT01473641
First received: November 15, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexplanon Observational Risk Assessment Study (NORA)

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Insertion-, localization- and removal-related events [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pregnancy and pregnancy outcomes [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: Yes ]
  • Reasons for (premature) discontinuation of Nexplanon [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: Yes ]
  • Baseline characteristics of Nexplanon users [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: No ]

Estimated Enrollment: 7100
Study Start Date: November 2011
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
New users of Nexplanon

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women using the contraceptive implant Nexplanon

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473641

Contacts
Contact: Klaas Heinemann, MD, MBA, PhD +49 30 945 101 24 k.heinemann@zeg-berlin.de
Contact: Suzanne Reed, MSc, PhD +49 30 945 101 63 reed@zeg-berlin.de

Locations
Germany
Center for Epidemiology and Health Research Recruiting
Berlin, Germany
Contact: Klaas Heinemann, MD, MBA, PhD    +49 30 945 101 24    k.heinemann@zeg-berlin.de   
Contact: Suzanne Reed, MSc, PhD    +49 30 945 101 63    reed@zeg-berlin.de   
Principal Investigator: Klaas Heinemann, MD, MBA, PhD         
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Klaas Heinemann, MD, MBA, PhD Center for Epidemiology and Health Research, Berlin, Germany
  More Information

No publications provided

Responsible Party: Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01473641     History of Changes
Other Study ID Numbers: ZEG2011_03
Study First Received: November 15, 2011
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Epidemiology and Health Research, Germany:
Etonogestrel
Contraceptive implant
Safety

Additional relevant MeSH terms:
3-keto-desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014