Contraception
Conditions
Keywords
Etonogestrel, Contraceptive implant, Safety
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Center for Epidemiology and Health Research, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion-, localization- and removal-related events | Within 42 months after insertion | 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
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | Within 42 months after insertion | Pre-treatment, in-treatment, post-treatment and non-insertion pregnancies. |
| Pregnancy outcomes | Within 42 months after insertion | Pregnancy outcomes in pregnancies where fetal exposure to etonogestrel may have taken place. |
| Reasons for (premature) discontinuation of Nexplanon | Within 42 months after insertion | The reason(s) the patient had the implant removed. |
| Baseline characteristics of Nexplanon users | Within 42 months after insertion | Baseline characteristics (including contraceptive history, medical history, gynecological history and socio-demongraphic details). |
Countries
Germany
Outcome results
None listed