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NCT01411995 · ClinicalTrials.gov registry record · NA
Cervical Lidocaine for Intrauterine Device Insertion Pain
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01411995: Completed NA study, sponsored by Washington University School of Medicine.
NCT01411995 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01411995, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.
Primary Outcome
Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required. Range: 0-10 (0= no pain, 10=worst pain)
Interventions
- DRUG 2% lidocaine gel
- DRUG Water based lubricant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-12 |
| Phase | NA |
What the finished NCT01411995 record still lists
NCT01411995 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which 2% lidocaine gel is the first listed.
NCT01411995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01411995 about?
NCT01411995 is a clinical study titled "Cervical Lidocaine for Intrauterine Device Insertion Pain". The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just bef...
What is the current status of trial NCT01411995?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2011-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01411995?
The interventions under investigation include: 2% lidocaine gel (DRUG), Water based lubricant (DRUG).
Who is sponsoring clinical trial NCT01411995?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01411995's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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