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Nexplanon Removal: Subcutaneous vs. Topical Lidocaine
Phase 4
Waitlist Available
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions
Pivotal Trial
Summary
This trial is testing whether EMLA cream is more effective than lidocaine for pain during and time to removal of Nexplanon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
pain of procedure
time to perform procedure
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EMLAExperimental Treatment1 Intervention
Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.
Group II: Subcutaneous LidocaineActive Control1 Intervention
Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,650 Total Patients Enrolled