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NCT01214161 · ClinicalTrials.gov registry record · NA
Intracervical Lidocaine Gel for IUD Insertional Pain
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01214161: Completed NA study, sponsored by Columbia University.
NCT01214161 is a NA study that has completed, run by Columbia University. 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
NCT01214161, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain
Primary Outcome
Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.
Interventions
- OTHER placebo
- DRUG 2% lidocaine gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01214161 record still lists
NCT01214161 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 placebo is the first listed.
NCT01214161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01214161 about?
NCT01214161 is a clinical study titled "Intracervical Lidocaine Gel for IUD Insertional Pain". The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this met...
What is the current status of trial NCT01214161?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2010-10. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01214161?
The interventions under investigation include: placebo (OTHER), 2% lidocaine gel (DRUG).
Who is sponsoring clinical trial NCT01214161?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01214161'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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