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NCT03654417 · ClinicalTrials.gov registry record · Phase 4
Pain Perception During Vulvar Biopsy
A Phase 4 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT03654417: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT03654417 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654417, a Phase 4 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to compare pain control during vulvar biopsy following either (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and prilocaine 2.5%) cream or (2) injection of 1% lidocaine. We hypothesize that lidocaine will provide better biopsy analgesia, but the benefit will be offset by the pain of lidocaine injection compared to EMLA application, thus there will not be a significant difference in highest pain scores between the two groups.
Primary Outcome
The highest pain score recorded (at time of numbing or at time of biopsy) controlled for baseline pain title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during numbing OR biopsy min: 0 (no pain) max: 100 (worst pain imaginable)
Interventions
- DRUG Lidocaine
- DRUG EMLA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2019-03-12 |
| Phase | Phase 4 |
Why NCT03654417 stopped before completion
NCT03654417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT03654417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03654417 about?
NCT03654417 is a clinical study titled "Pain Perception During Vulvar Biopsy". The purpose of this study is to compare pain control during vulvar biopsy following either (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and prilocaine 2.5%) cream or (2) injection of 1% lidocaine. We hypothesize that lidocaine will provide better biopsy analgesia, ...
What is the current status of trial NCT03654417?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2018-09-17. Estimated completion is 2019-03-12.
What interventions are being tested in trial NCT03654417?
The interventions under investigation include: Lidocaine (DRUG), EMLA (DRUG).
Who is sponsoring clinical trial NCT03654417?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03654417's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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